Weight management using meal replacements and cardiometabolic risk reduction in individuals with pre-diabetes and features of metabolic syndrome: A systematic review and meta-analysis of randomized controlled trials.

This review synthesized the evidence from randomized controlled trials comparing the effect of meal replacements (MRs) as part of a weight loss intervention with conventional food-based weight loss diets on cardiometabolic risk in individuals with pre-diabetes and features of metabolic syndrome. MEDLINE, EMBASE, and Cochrane Library were searched through January 16, 2024. Data were pooled using the generic inverse variance method and expressed as mean difference [95% confidence intervals]. The overall certainty of the evidence was assessed using GRADE. Ten trials (n = 1254) met the eligibility criteria. MRs led to greater reductions in body weight (-1.38 kg [-1.81, -0.95]), body mass index (BMI, -0.56 kg/m2 [-0.78, -0.34]), waist circumference (-1.17 cm [-1.93, -0.41]), HbA1c (-0.11% [-0.22, 0.00]), LDL-c (-0.18 mmol/L [-0.28, -0.08]), non-HDL-c (-0.17 mmol/L [-0.33, -0.01]), and systolic blood pressure (-2.22 mmHg [-4.20, -0.23]). The overall certainty of the evidence was low to moderate owing to imprecision and/or inconsistency. The available evidence suggests that incorporating MRs into a weight loss intervention leads to small important reductions in body weight, BMI, LDL-c, non-HDL-c, and systolic blood pressure, and trivial reductions in waist circumference and HbA1c, beyond that seen with conventional food-based weight loss diets.

Ketogenic nutritional therapy (KeNuT)-a multi-step dietary model with meal replacements for the management of obesity and its related metabolic disorders: a consensus statement from the working group of the Club of the Italian Society of Endocrinology (SIE)-diet therapies in endocrinology and metabolism.

PURPOSE: The ketogenic nutritional therapy (KeNuT) is an effective dietary treatment for patients with obesity and obesity-related comorbidities, including type 2 diabetes, dyslipidaemia, hypertension, coronary artery disease, and some type of cancers. However, to date an official document on the correct prescription of the ketogenic diet, validated by authoritative societies in nutrition or endocrine sciences, is missing. It is important to emphasize that the ketogenic nutritional therapy requires proper medical supervision for patient selection, due to the complex biochemical implications of ketosis and the need for a strict therapeutic compliance, and an experienced nutritionist for proper personalization of the whole nutritional protocol. METHODS: This practical guide provides an update of main clinical indications and contraindications of ketogenic nutritional therapy with meal replacements and its mechanisms of action. In addition, the various phases of the protocol involving meal replacements, its monitoring, clinical management and potential side effects, are also discussed. CONCLUSION: This practical guide will help the healthcare provider to acquire the necessary skills to provide a comprehensive care of patients with overweight, obesity and obesity-related diseases, using a multistep ketogenic dietary treatment, recognized by the Club of the Italian Society of Endocrinology (SIE)-Diet Therapies in Endocrinology and Metabolism.

Importance of early weight loss and other predictors of lower weight loss in a commercial program: A secondary data analysis.

Objective: There is substantial inter-individual variability in response to weight loss interventions and emerging evidence suggests that weight loss during the early weeks of an intervention may be predictive of longer-term weight loss. This secondary analysis of data from a commercial program therefore examined 1) the associations between early weight loss (i.e., week 4) with final visit weight loss and duration on the program, and 2) other predictors of lower weight loss at final visit. Methods: Client charts of adults with overweight or obesity (N = 748) were analyzed. Clients were stratified into categories of weight loss at the week 4 (< and ≥2%, 3% and 4%) and final visits (< and ≥5% and 10%). Multivariate logistic regression was used to assess predictors of <5% and <10% final visit weight loss. Results: The odds ratios for losing <5% or <10% of weight at the final visit were higher (49.0 (95% CI: 13.84, 173.63) and 20.1 (95% CI: 6.96, 58.06)) for clients who lost <2% or <3% compared to those who lost ≥2% or ≥3% at week 4. Other predictors of not losing a clinically relevant amount of weight included female sex, use of higher calorie meal plans and shorter time in the program, among others. Those who lost ≥2% at week 4 also had a significantly greater percent program completion (109.2 ± 75.2% vs. 82.3 ± 82.4, p < 0.01) compared with those who did not meet the 2% threshold. Conclusions: Lower 4-week weight loss was identified as a strong predictor of not losing a clinically relevant amount of weight. These results may be useful for the early identification of individuals who can be targeted for additional counseling and support to aid in attaining weight loss goals.

Effectiveness of ketogenic diet in treatment of patients with refractory chronic migraine.

BACKGROUND AND PURPOSE: Ketogenic diet (KD) is based on restriction of carbohydrate intake. Metabolism is forced to obtain energy starting from ß-oxidation of fatty acids which, turned into ketone bodies, can also be used by central nervous system (CNS). KD use in treatment of chronic migraine has recently been considered. We set out to verify modification of symptoms in patients with refractory chronic migraine in response to KD. METHODS: Fifty patients were enrolled of which 38 completed the procedures the study and 23 were considered in the statistics. All of the patients considered in our study were affected by medication overuse headache (MOH). They were on a KD for 3 months. The following parameters have been checked at t = 0 and every 30 days for 6 months: migraine episode length (n. hours/day), frequency (n. days/month), level of pain of every episode measured on a scale from 1 to 3 (1 = mild; 2 = moderate; 3 = severe), and n. analgesic drugs taken/month. RESULTS: Days with symptoms decreased from 30 (median value) to 7.5 with p < 0.0001. The duration of the migraine episodes decreased from 24 h (median value) to 5.5 h with p < 0.0016. The patients' pain level, initially at maximum value for 83% of the participants, improved for 55% of them (p < 0.0024). The number of drugs taken in a month decreased from 30 doses (median value) to 6 doses. CONCLUSIONS: It can be stated that a 3-month KD resulted in a reduction of painful symptoms of drug refractory chronic migraine. This result may suggest an improvement in quality of life of the patients, even without a tabulated data collection.

Dietary Patterns and Cardiometabolic Outcomes in Diabetes: A Summary of Systematic Reviews and Meta-Analyses.

The Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD) conducted a review of existing systematic reviews and meta-analyses to explain the relationship between different dietary patterns and patient-important cardiometabolic outcomes. To update the clinical practice guidelines for nutrition therapy in the prevention and management of diabetes, we summarize the evidence from these evidence syntheses for the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), Portfolio, Nordic, liquid meal replacement, and vegetarian dietary patterns. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence. We summarized the evidence for disease incidence outcomes and risk factor outcomes using risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively. The Mediterranean diet showed a cardiovascular disease (CVD) incidence (RR: 0.62; 95%CI, 0.50, 0.78), and non-significant CVD mortality (RR: 0.67; 95%CI, 0.45, 1.00) benefit. The DASH dietary pattern improved cardiometabolic risk factors (P < 0.05) and was associated with the decreased incidence of CVD (RR, 0.80; 95%CI, 0.76, 0.85). Vegetarian dietary patterns were associated with improved cardiometabolic risk factors (P < 0.05) and the reduced incidence (0.72; 95%CI: 0.61, 0.85) and mortality (RR, 0.78; 95%CI, 0.69, 0.88) of coronary heart disease. The Portfolio dietary pattern improved cardiometabolic risk factors and reduced estimated 10-year coronary heart disease (CHD) risk by 13% (-1.34% (95%CI, -2.19 to -0.49)). The Nordic dietary pattern was correlated with decreased CVD (0.93 (95%CI, 0.88, 0.99)) and stroke incidence (0.87 (95%CI, 0.77, 0.97)) and, along with liquid meal replacements, improved cardiometabolic risk factors (P < 0.05). The evidence was assessed as low to moderate certainty for most dietary patterns and outcome pairs. Current evidence suggests that the Mediterranean, DASH, Portfolio, Nordic, liquid meal replacement and vegetarian dietary patterns have cardiometabolic advantages in populations inclusive of diabetes.

Prenatal Intervention with Partial Meal Replacement Improves Micronutrient Intake of Pregnant Women with Obesity.

A behavioral lifestyle intervention with partial meal replacement reduced excess gestational weight gain in ethnically diverse women with overweight/obesity, but the effects on micronutrient intake remained unknown. A secondary analysis of a randomized, controlled trial tested whether the intervention improved micronutrient intake relative to usual care. Pregnant women (n = 211; 30.5 years of age, body mass index, BMI, of 32.0 kg/m2) were enrolled and randomized within site and ethnicity (40% were Hispanic) into intervention (n = 102) or usual care (n = 109) groups. Two 24 h dietary recalls were conducted on random days at study entry and late pregnancy (35⁻36 weeks gestation). Nutrient adequacy was defined using the Estimated Average Requirement cut-point method. At study entry and including prenatal vitamins, ≥90% of participants reported inadequate intake of vitamins D and E and iron; 40⁻50% reported inadequate intake of calcium, protein, vitamins A, C, B6, folate, magnesium, and zinc. From study entry to late pregnancy, the behavioral intervention with partial meal replacement increased the overall intake of vitamins A, E, and D and copper and reduced the odds of inadequate intake of calcium (odds ratio (OR) = 0.37 (0.18, 0.76)), vitamins A (OR = 0.39 (0.21, 0.72)) and E (OR = 0.17 (0.06, 0.48)), and magnesium (OR = 0.36 (0.20, 0.65)). A behavioral intervention with partial meal replacement during pregnancy improved the intake of several micronutrients in Hispanic and non-Hispanic women with overweight/obesity.

Randomized controlled trial assessing two commercial weight loss programs in adults with overweight or obesity.

OBJECTIVE: Lifestyle interventions remain the cornerstone for obesity treatment. Commercial programs offer one weight loss approach, yet the efficacy of few such programs have been rigorously investigated. The purpose of this study was to evaluate the efficacy of two commercial weight-loss programs, both utilizing pre-portioned meal replacements (MRs) and different levels of behavioural support, compared to a self-directed control diet in adults with overweight and obesity. METHODS: In this 16-week study, participants were randomized to the low-calorie OPTAVIA® 5&1 Plan® with telephone coaching (OPT), the reduced-calorie Medifast® 4&2&1 self-guided plan (MED), or a self-directed, reduced-calorie control diet. Differences in weight, body composition (DXA) and body circumferences, all measured monthly, were assessed by analysis of covariance with sex and baseline measures as covariates. RESULTS: Of 198 participants randomized (80.8% female, BMI 34.2 kg/m2, 45.7 years), 92.3% completed the study. The OPT and MED groups had significantly greater reductions in body weight (-5.7% and - 5.0%, respectively, p < 0.0001), fat and abdominal fat mass (p < 0.0001) and waist and hip circumferences (p ≤ 0.003) than control at 16 weeks. Weight change was correlated with MR usage and completion of coaching support calls. CONCLUSIONS: Both structured commercial programs were more efficacious than a self-directed, reduced-calorie diet for weight loss and other anthropometric measures. Evidence-based commercial programs can be an important tool to help adults with overweight and obesity lose clinically relevant amounts of weight.

Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial.

Background: Lifestyle change treatments for weight loss produce medically meaningful weight reductions, but lost weight is usually regained. Meal replacements (MRs) represent one avenue for improving long-term weight loss. Another, nutrition-focused approach involves having participants make specific changes in the energy density, composition, and structure of the foods in their personal food environments. Objective: Three conditions were compared: behavior therapy (BT), BT plus MRs (BT+MR), and a nutrition-focused treatment aimed at modifying the home food environment (HFE). Design: Overweight and obese individuals (n = 262) were randomly assigned to 1 of the 3 conditions. Treatment occurred in weekly groups for 6 mo and in biweekly groups for 6 mo. Assessments were conducted at baseline and at 6, 12, 18, 24, and 36 mo. Multilevel models were used to estimate weight-change trajectories for each participant and to examine the treatment group effect on long-term weight loss. Results: A multilevel analysis indicated that all 3 groups showed significant weight loss over 12 mo that was gradually regained to the 36-mo follow-up. Mean ± SD percentages of baseline weight loss at 12 mo for BT, BT+MR, and HFE were 9.41% ± 7.92%, 10.37% ± 7.77%, and 10.97% ± 7.79%, respectively. Comparable percentages at 36 mo were 4.21% ± 8.64%, 3.06% ± 6.93%, and 4.49% ± 7.83%. Those in the HFE condition lost more weight than those receiving BT through the 36-mo assessment (P < 0.01), as reflected in 2 treatment × time interactions. Further analyses showed that HFE produced the largest increases in cognitive restraint and that this increase largely mediated the HFE group's improved weight loss. Conclusion: The nutrition-focused intervention studied here produced modestly greater long-term weight loss than BT, an effect that was largely explainable by an unexpected boost in cognitive restraint in this condition. This study was registered at clinicaltrials.gov as NCT01065974.

Nutrient Intake During Diet-Induced Weight Loss and Exercise Interventions in a Randomized Trial in Older Overweight and Obese Adults.

OBJECTIVES: Dietary restriction in obese older adults undergoing weight loss may exacerbate nutrient deficiencies common in this group; the nutritional health of older adults is a factor in their quality of life, disability, and mortality. This study examined the effect of an 18-month weight loss program based in social cognitive theory incorporating partial meal replacements, on nutrient intake in older overweight and obese adults. DESIGN: The following analysis is from the Intensive Diet and Exercise for Arthritis (IDEA) trial, a single-blind, randomized controlled trial. Individuals were randomized into one of three 18-month interventions: exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E). SETTING: The study setting was at a university research facility. PARTICIPANTS: Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited. INTERVENTIONS: The D and D+E interventions (group mean goal of ≥10% loss by 18-months) utilized partial meal replacements (2 meal replacement shakes/day for 6-months). Exercise training for E and D+E was 3 days/week, 60 minutes/day. MEASUREMENTS: Three day food records were collected at baseline, 6-months, and 18-months and analyzed for total energy and macro- and micronutrient intake. Comparisons of dietary intake among treatment groups were performed at 6 and 18 months using mixed linear models. RESULTS: Weight loss at 18-months was 11.3±8.3% (D), 10.3±6.8% (D+E), and 1.2±4.2% (E). Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E. Both D and D+E consumed less energy and fat, and more carbohydrates and selected micronutrients than E during follow-up. More than 50% of all participants consumed less than the recommended intake of particular vitamins and minerals. CONCLUSIONS: The diet intervention improved intakes of several nutrients. However, inadequate intake of several vitamins and minerals of concern for older adults suggests they need further guidance to assure adequate intake.

Commercial Very Low Energy Meal Replacements for Preoperative Weight Loss in Obese Patients: a Systematic Review.

BACKGROUND: This systematic review assessed feasibility and effectiveness of preoperative meal replacements to improve surgical outcomes for obese patients. METHODS: PRISMA guidelines were followed and electronic databases searched for articles between January 1990 and March 2015. RESULTS: Fifteen studies (942 participants including 351 controls) were included, 13 studies (n = 750) in bariatric patients. Adverse effects and dropout rates were minimal. Ten out of 14 studies achieved 5-10 % total weight loss. Six of six studies reporting liver volume achieved 10 % reduction. Endpoints for perioperative risks and outcomes were too varied to support definitive risk benefit. CONCLUSIONS: Commercial meal replacements are feasible, have minimal side effects and facilitate weight loss and liver shrinkage in free-living obese patients awaiting elective surgery. A reduction in surgical risk is unclear.

Nutritional Therapy.

This article provides the reader with steps needed to accurately assess patient nutrition behaviors that contribute to weight gain, inability to lose weight, or inability to sustain weight loss. Evidence-based approaches in nutrition therapy that can create the daily energy deficit needed to produce 1/2 to 2 pounds of weight loss per week, and the strategies to create the energy deficit, are presented. To optimize health, long-term weight loss maintenance is needed. The benefits of using a multidisciplinary team approach in treating obesity are highlighted.

Successful Medical Weight Loss in a Community Setting.

BACKGROUND: Research has shown that meal replacement calorie reduction combined with lifestyle change can more than double the weight loss seen with other diets. However, its widespread acceptance by physicians has been limited, perhaps waiting on evidence that patients are successful in keeping lost weight off. METHODS: Obese patients (108.4 ± 25.7 kg, BMI 38.1 ± 7.9 kg/m2) used a diet of meal replacements combined with weekly classes. While learning about nutrition, exercise, and accountability, patients tracked calorie intake and physical activity. Weight loss and retention rates for rapid weight loss and maintenance phases were measured. Weights then obtained years after treatment ended showed that patients were keeping lost weight off without any ongoing clinic intervention. RESULTS: Records of 714 patients treated in a medical weight loss practice from 2004 through 2012 were reviewed. For all patients, weight loss was 13.6 ± 8.3 kg, and 12.5% of initial weight. The 469 patients who completed 16 weeks of weight loss classes lost 16.7 ± 7.2 kg and 15.1%. 433 patients then enrolled in maintenance classes, and after 12 months had regained only 0.1 ± 9.1 kg and 0.4%. Follow up weights obtained from 173 patients more than 2 years after treatment ended showed persisting weight loss of 14.3 ± 13.7 kg and 12.9%. Final BMI was 32.7 ± 7.7 kg/m2. CONCLUSION: In a medical weight loss program that used meal replacements to reduce calorie intake combined with weekly behavior change classes, weight loss was 16.2 kg and 14.4% for the 61% of all enrollees who completed 16 months of treatment. More importantly, over 2 years later, weight loss of 14.3 kg and 12.9% of initial weight persisted, and patients were not regaining their lost weight.

Meal replacements as a weight loss tool in a population with severe mental illness.

Weight gain and worsening metabolic parameters are often side effects of antipsychotic medications used by individuals with severe mental illness. To address this, a randomized, controlled research study of a behavioral weight management program for individuals with severe mental illness was undertaken to assess its efficacy. Patients unable to meet weight loss goals during the first portion of the year-long study were given the option of using meal replacement shakes in an effort to assist with weight loss. Specific requirements for use of meal replacement shakes were specified in the study protocol; only five patients were able to use the shakes in accordance with the protocol and lose weight while improving metabolic parameters. Case studies of two subjects are presented, illustrating the challenges and obstacles they faced, as well as their successes. Taking responsibility for their own weight loss, remaining motivated through the end of the study, and incorporating the meal replacement shakes into a daily routine were factors found in common with these patients. Use of meal replacements shakes with this population may be effective.

Comparing the effects of meal replacements with an isocaloric reduced-fat diet on nutrient intake and lower urinary tract symptoms in obese men.

BACKGROUND: Lower urinary tract symptoms (LUTS) in men are associated with obesity, particularly central obesity as measured by waist circumference (WC), and may improve with weight loss. We aimed to compare effects of a meal-replacement based diet with isocaloric reduced-fat plan on LUTS and nutrient intake in obese Asian men. METHODS: Obese Asian [mean (range) body mass index of 32.9 (30.5-42.3) kg m(-2) ] men [mean (range) age 40.2 (30-61) years] were randomised to a reduced-fat (< 30% of energy) diet [conventional reduced-fat diet (CD) group; n = 23] or meal-replacement-based plan [meal replacement (MR) group; n = 23], to reduce daily intake by 2000 kJ for 12 weeks. RESULTS: CD and MR groups had statistically significant and similar reductions in weight (-2.6 ± 1.9 kg versus -4.2 ± 3.8 kg), overall LUTS severity measured with International Prostate Symptom Scale (IPSS) scores (-1.71 ± 1.93 points versus -2.42 ± 2.12 points) and insulin resistance [homeostasis model assessment (HOMA) calculated from plasma glucose and insulin]. The MR group had significantly greater decreases in WC (-4.8 ± 3.3 cm versus -2.5 ± 2.3 cm), fat mass (-2.47 ± 3.63 kg versus -1.59 ± 2.32 kg), fat intake, plasma C-reactive protein, and in storage LUTS score (-1.59 ± 1.33 points versus -1.00 ± 0.87 points), which was associated with a decreased fat intake (r = 0.48, P = 0.03). A decrease in overall IPSS score was associated with reductions in weight, WC and HOMA. CONCLUSIONS: Weight loss as a result of CD or MR had similar efficacy in relieving LUTS. MR produced greater reductions in fat intake, adiposity and storage LUTS.

A pilot randomized trial comparing a commercial weight loss program with a clinic-based intervention for weight loss.

OBJECTIVE: To compare the efficacy of a popular commercial program with that of a clinic-based intervention for weight loss. METHODS: Randomized clinical trial conducted at an internal medicine clinic affiliated with a city hospital in Denver, Colorado. Participant (n = 46) had a body mass index ≥ 30 kg/m(2) and no life-threatening medical conditions. They either were provided a voucher to attend Weight Watchers for 17 weeks (n = 23), or they were assigned to the clinic group (n = 23), which provided 12 visits over 17 weeks and the option to augment weight loss using either meal replacements or weight loss medication. The primary study outcome was weight change. RESULTS: Participants assigned to the clinic arm lost 4.0 ± 1.2 kg, compared to 0.4 ± 1.1 for those assigned to the commercial program (P = .04 for difference). Weight losses in the clinic arm were 3.2 kg for meal replacements (n = 10) and 5.0 kg for phentermine (n = 13). CONCLUSIONS: In this single-site trial, a clinic-based intervention was more effective than a popular commercial program for weight loss. Primary care providers in the United States are under increasing pressure to combat the epidemic of obesity. This trial, although small, begins to address how the primary care setting might play that role.