The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial.

PURPOSE: To examine the cost effectiveness of dietary advice to increase protein intake on 6-month change in physical functioning among older adults. METHODS: In this multicenter randomized controlled trial, 276 community-dwelling older adults with a habitual protein intake < 1.0 g/kg adjusted body weight (aBW)/d were randomly assigned to either Intervention 1; advice to increase protein intake to ≥ 1.2 g/kg aBW/d (PROT, n = 96), Intervention 2; similar advice and in addition advice to consume protein (en)rich(ed) foods within half an hour after usual physical activity (PROT + TIMING, n = 89), or continue the habitual diet with no advice (CON, n = 91). Primary outcome was 6-month change in 400-m walk time. Secondary outcomes were 6-month change in physical performance, leg extension strength, grip strength, body composition, self-reported mobility limitations and quality of life. We evaluated cost effectiveness from a societal perspective. RESULTS: Compared to CON, a positive effect on walk time was observed for PROT; - 12.4 s (95%CI, - 21.8 to - 2.9), and for PROT + TIMING; - 4.9 s (95%CI, - 14.5 to 4.7). Leg extension strength significantly increased in PROT (+ 32.6 N (95%CI, 10.6-54.5)) and PROT + TIMING (+ 24.3 N (95%CI, 0.2-48.5)) compared to CON. No significant intervention effects were observed for the other secondary outcomes. From a societal perspective, PROT was cost effective compared to CON. CONCLUSION: Dietary advice to increase protein intake to ≥ 1.2 g/kg aBW/d improved 400-m walk time and leg strength among older adults with a lower habitual protein intake. From a societal perspective, PROT was considered cost-effective compared to CON. These findings support the need for re-evaluating the protein RDA of 0.8 g/kg BW/d for older adults. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (NCT03712306). Date of registration: October 2018. Registry name: The (Cost) Effectiveness of Increasing Protein Intake on Physical Functioning in Older Adults. Trial Identifier: NCT03712306.

Can Healthy Checkout Counters Improve Food Purchases? Two Real-Life Experiments in Dutch Supermarkets.

Most snacks displayed at supermarket checkouts do not contribute to a healthy diet. We investigated the effects of introducing healthier snack alternatives at checkouts in supermarkets on purchasing behavior. In Study 1, we investigated the effect of completely substituting less healthy with healthier snacks (one supermarket). In Study 2, we investigated the effect of placing and discounting healthier snacks while the less healthy snacks remain in place (two supermarkets). In both studies, the number of purchased snacks (per 1000 customers) was used as the outcome variable. Results for Study 1 showed that the absolute number of purchased checkout snacks was 2.4 times lower (95% confidence interval (CI): 1.9-2.7) when healthier snacks instead of less healthy snacks were placed at the supermarket checkouts. Results for Study 2 showed that when additional healthier snacks were placed near the checkouts, the absolute number of healthier purchased snacks increased by a factor of 2.1 (95% CI: 1.3-3.3). When additional healthier snacks were placed near the checkouts and discounted, the absolute number of healthier purchased snacks increased by a factor of 2.7 (95% CI: 2.0-3.6), although this was not statistically significant higher than placement only (ratio: 1.1, 95% CI: 0.7-1.9). Purchases of less healthy snacks did not decline, and even slightly increased, during the intervention period (ratio: 1.3, 95% CI: 1.1-1.5). If supermarkets want to promote healthier snack purchases, additional healthier products can be positioned near the checkouts. However, this does not discourages the purchase of less healthy snacks. Therefore, to discourage unhealthy snack purchases at supermarket checkouts, a total substitution of less healthy snacks with healthier alternatives is most effective.

Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial.

INTRODUCTION: Short-term metabolic and observational studies suggest that protein intake above the recommended dietary allowance of 0.83 g/kg body weight (BW)/day may support preservation of lean body mass and physical function in old age, but evidence from randomised controlled trials is inconclusive. METHODS AND ANALYSIS: The PRevention Of Malnutrition In Senior Subjects in the EU (PROMISS) trial examines the effect of personalised dietary advice aiming at increasing protein intake with or without advice regarding timing of protein intake to close proximity of usual physical activity, on change in physical functioning after 6 months among community-dwelling older adults (≥65 years) with a habitual protein intake of <1.0 g/kg adjusted (a)BW/day. Participants (n=264) will be recruited in Finland and the Netherlands, and will be randomised into three groups; two intervention groups and one control group. Intervention group 1 (n=88) receives personalised dietary advice and protein-enriched food products in order to increase their protein intake to at least 1.2 g/kg aBW/day. Intervention group 2 (n=88) receives the same advice as described for intervention group 1, and in addition advice to consume 7.5-10 g protein through protein-(en)rich(ed) foods within half an hour after performing usual physical activity. The control group (n=88) receives no intervention. All participants will be invited to attend lectures not related to health. The primary outcome is a 6-month change in physical functioning measured by change in walk time using a 400 m walk test. Secondary outcomes are: 6-month change in the Short Physical Performance Battery score, muscle strength, body composition, self-reported mobility limitations, quality of life, incidence of frailty, incidence of sarcopenia risk and incidence of malnutrition. We also investigate cost-effectiveness by change in healthcare costs. DISCUSSION: The PROMISS trial will provide evidence whether increasing protein intake, and additionally optimising the timing of protein intake, has a positive effect on the course of physical functioning after 6 months among community-dwelling older adults with a habitual protein intake of <1.0 g/kg aBW/day. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Helsinki University Central Hospital, Finland (ID of the approval: HUS/1530/2018) and The Medical Ethical Committee of the Amsterdam UMC, location VUmc, Amsterdam, the Netherlands (ID of the approval: 2018.399). All participants provided written informed consent prior to being enrolled onto the study. Results will be submitted for publication in peer-reviewed journals and will be made available to stakeholders (ie, older adults, healthcare professionals and industry). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03712306).

Impact of Masked Replacement of Sugar-Sweetened with Sugar-Free Beverages on Body Weight Increases with Initial BMI: Secondary Analysis of Data from an 18 Month Double-Blind Trial in Children.

BACKGROUND: Substituting sugar-free for sugar-sweetened beverages reduces weight gain. This effect may be more pronounced in children with a high body mass index (BMI) because their sensing of kilocalories might be compromised. We investigated the impact of sugar-free versus sugary drinks separately in children with a higher and a lower initial BMI z score, and predicted caloric intakes and degree of compensation in the two groups. METHODS AND FINDINGS: This is a secondary, explorative analysis of our double-blind randomized controlled trial (RCT) which showed that replacement of one 250-mL sugary drink per day by a sugar-free drink for 18 months significantly reduced weight gain. In the 477 children who completed the trial, mean initial weights were close to the Dutch average. Only 16% were overweight and 3% obese. Weight changes were expressed as BMI z-score, i.e. as standard deviations of the BMI distribution per age and sex group. We designated the 239 children with an initial BMI z-score below the median as 'lower BMI' and the 238 children above the median as 'higher BMI'. The difference in caloric intake from experimental beverages between treatments was 86 kcal/day both in the lower and in the higher BMI group. We used a multiple linear regression and the coefficient of the interaction term (initial BMI group times treatment), indicated whether children with a lower BMI responded differently from children with a higher BMI. Statistical significance was defined as p ≤ 0.05. Relative to the sugar sweetened beverage, consumption of the sugar-free beverage for 18 months reduced the BMI z-score by 0.05 SD units within the lower BMI group and by 0.21 SD within the higher BMI group. Body weight gain was reduced by 0.62 kg in the lower BMI group and by 1.53 kg in the higher BMI group. Thus the treatment reduced the BMI z-score by 0.16 SD units more in the higher BMI group than in the lower BMI group (p = 0.04; 95% CI -0.31 to -0.01). The impact of the intervention on body weight gain differed by 0.90 kg between BMI groups (p = 0.09; 95% CI -1.95 to 0.14). In addition, we used a physiologically-based model of growth and energy balance to estimate the degree to which children had compensated for the covertly removed sugar kilocalories by increasing their intake of other foods. The model predicts that children with a lower BMI had compensated 65% (95% CI 28 to 102) of the covertly removed sugar kilocalories, whereas children with a higher BMI compensated only 13% (95% CI -37 to 63). CONCLUSIONS: The children with a BMI above the median might have a reduced tendency to compensate for changes in caloric intake. Differences in these subconscious compensatory mechanisms may be an important cause of differences in the tendency to gain weight. If further research bears this out, cutting down on the intake of sugar-sweetened drinks may benefit a large proportion of children, especially those who show a tendency to become overweight. TRIAL REGISTRATION: ClinicalTrials.gov NCT00893529.

Testing for baseline differences in randomized controlled trials: an unhealthy research behavior that is hard to eradicate.

BACKGROUND: According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that co-authors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. DISCUSSION: Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore.

The effect of sugar-free versus sugar-sweetened beverages on satiety, liking and wanting: an 18 month randomized double-blind trial in children.

BACKGROUND: Substituting sugar-free for sugar-sweetened beverages reduces weight gain. A possible explanation is that sugar-containing and sugar-free beverages cause the same degree of satiety. However, this has not been tested in long-term trials. METHODS: We randomized 203 children aged 7-11 years to receive 250 mL per day of an artificially sweetened sugar-free beverage or a similarly looking and tasting sugar-sweetened beverage. We measured satiety on a 5-point scale by questionnaire at 0, 6, 12 and 18 months. We calculated the change in satiety from before intake to 1 minute after intake and 15 minutes after intake. We then calculated the odds ratio that satiety increased by 1 point in the sugar-group versus the sugar-free group. We also investigated how much the children liked and wanted the beverages. RESULTS: 146 children or 72% completed the study. We found no statistically significant difference in satiety between the sugar-free and sugar-sweetened group; the adjusted odds ratio for a 1 point increase in satiety in the sugar group versus the sugar-free group was 0.77 at 1 minute (95% confidence interval, 0.46 to 1.29), and 1.44 at 15 minutes after intake (95% CI, 0.86 to 2.40). The sugar-group liked and wanted their beverage slightly more than the sugar-free group, adjusted odds ratio 1.63 (95% CI 1.05 to 2.54) and 1.65 (95% CI 1.07 to 2.55), respectively. CONCLUSIONS: Sugar-sweetened and sugar-free beverages produced similar satiety. Therefore when children are given sugar-free instead of sugar-containing drinks they might not make up the missing calories from other sources. This may explain our previous observation that children in the sugar-free group accumulated less body fat than those in the sugar group. TRIAL REGISTRATION: ClinicalTrials.gov NCT00893529 http://clinicaltrials.gov/show/NCT00893529.

Ready-to-eat cereals are key sources of selected micronutrients among schoolchildren from public and private elementary schools in Quetzaltenango, Guatemala.

This cross-sectional dietary survey aimed to assess the consumption and relative nutrient contribution of ready-to-eat cereals (RTEC) among schoolchildren from 2 social classes in an urban center in the Guatemalan province of Quetzaltenango. A total of 449 24-hour dietary records were collected using a pictorial workbook registry method among third- and fourth-grade schoolchildren. The sample population was divided between low-income, public school attendants (n = 219) and students from higher-income private institutions (n = 230). We described the contribution of RTEC to estimated total energy; carbohydrates; protein; fat; vitamins A, C, and D; thiamin; riboflavin; folate; calcium; iron; and zinc over the 24-hour interval of registry. Approximately 41% of the subjects mentioned RTEC at least once in their 24-hour record; 93% of these at breakfast time. From the 7 RTEC varieties reported, 4 were presweetened. Estimated cereal consumption was significantly higher among private school participants (P < .001). The RTEC contributed 2.4% of estimated total energy across the whole sample and 3.6% of total carbohydrate; iron intake from RTEC was 21% of total, whereas less than 1% of calcium intake came from this source. Among the subgroup of cereal consumers, RTEC accounted for more than 40% of their daily recommendation intake for iron, vitamin C, thiamin, and riboflavin. The RTEC consumers had significantly higher intakes for all nutrients except carbohydrate and riboflavin as compared with nonconsumers. This study demonstrates the importance of RTEC as a key source of several selected micronutrients to schoolchildren's diet in this setting.

Distribution of macro- and micronutrient intakes in relation to the meal pattern of third- and fourth-grade schoolchildren in the city of Quetzaltenango, Guatemala.

OBJECTIVE: Our objective was to assess the distribution of energy, macro- and micronutrient intakes by meal (breakfast, lunch, dinner and combined snacks) in a cross-sectional sample of schoolchildren. DESIGN: Cross-sectional dietary survey in schoolchildren. SETTING: Twelve private and public schools in the urban setting of Quetzaltenango, Guatemala. SUBJECTS: A total of 449 schoolchildren (from higher and lower socio-economic strata) were enrolled in the study. METHODS: Each child completed a single, pictorial 24 h prospective diary and a face-to-face interview to check completeness and estimate portion sizes. Estimated daily intakes were examined by mealtime as: (i) absolute intakes; (ii) relative nutrient distribution; and (iii) critical micronutrient density (i.e. nutrient density in relation to the WHO Recommended Nutrient Intakes/median age-specific Guatemalan energy requirements). RESULTS: The daily distribution of energy intake was 24% at breakfast, 30% at lunch, 23% at dinner and 23% among snacks. Lunch was also the leading meal for macronutrients, providing 35% of proteins, 27% of fat and 30% of carbohydrate. The distribution of selected micronutrients did not follow the pattern of energy, insofar as lunch provided relatively more vitamin C and Zn, whereas breakfast led in terms of vitamins A and D, thiamin, riboflavin, folate, Ca and Fe. CONCLUSIONS: Meal-specific distribution of energy, macro- and micronutrients provides a unique and little used perspective for evaluation of children's habitual intake, and may provide guidance to strategies to improve dietary balance in an era of coexisting energy overnutrition and micronutrient inadequacy.

Cross-sectional growth references and implications for the development of an international growth standard for school-aged children and adolescents.

Normative data are needed to create a reference that indicates optimal development of weight in relation to height and age, particularly in the face of the unfolding obesity epidemic. The body-mass index (BMI) has some serious limitations: it is a relatively poor predictor of current and future fatness. Currently, however, there are few available alternatives, with the possible exception of waist circumference or skinfolds. The use of cross-sectional references to construct a BMI-reference curve is problematic when there are period and cohort effects. Ideally, a reference would be based on longitudinal data in populations with little underweight, overweight, and obesity. In the meantime cross-sectional data in appropriate populations could be used to construct BMI percentiles linking BMI values at age 5 to those at age 18 (or 21) that would correspond with adult BMI values reflecting optimal health (e.g., that would correspond to adult BMI values between 21 and 23 kg/m2).

Stoichiometry and food-chain dynamics.

Traditional models of chemostat systems looking at interactions between predator, prey and nutrients have used only a single currency, such as energy or nitrogen. In reality, growth of autotrophs and heterotrophs may be limited by various elements, e.g. carbon, nitrogen, phosphorous or iron. In this study we develop a dynamic energy budget model chemostat which has both carbon and nitrogen as currencies, and examine how the dual availability of these elements affects the growth of phytoplankton, trophic transfer to zooplankton, and the resulting stability of the chemostat ecosystem. Both species have two reserve pools to obtain a larger metabolic flexibility with respect to changing external environments. Mineral nitrogen and carbon form the base of the food chain, and they are supplied at a constant rate. In addition, the biota in the chemostat recycle nutrients by means of respiration and excretion, and organic detritus is recycled at a fixed rate. We use numerical bifurcation analysis to assess the model's dynamic behavior. In the model, phytoplankton is nitrogen limited, and nitrogen enrichment can lead to oscillations and multiple stable states. Moreover, we found that recycling has a destabilizing effect on the food chain due to the increased repletion of mineral nutrients. We found that both carbon and nitrogen enrichment stimulate zooplankton growth. Therefore, we conclude that the concept of single-element limitation may not be applicable in an ecosystem context.