Cholesterol-lowering effects of a new isolated soy protein with high levels of nondenaturated protein in hypercholesterolemic patients.

This study was undertaken to compare the effects on plasma cholesterol concentration of a new isolated soy protein in which the protein structure is kept in its native, nondenaturated form (verum 1) versus a conventional isolated soy protein (verum 2) and milk protein (placebo). This prospective, randomized, double-blind, placebo-controlled study was conducted in an outpatient clinical study center in Berlin, Germany. Over 8 wk, 120 patients (total cholesterol, 5.2-7.8 mmol/L) were given verum 1, verum 2, or placebo at a dosage of 25 g protein daily. At the end of the treatment period, total cholesterol levels were significantly reduced by 10.7% in the verum 1 group compared with placebo (P<.001), and levels were reduced by 5.8% in the verum 2 group (P=.008). The difference between the 2 verum groups was statistically significant (P=.008). Low-density lipoprotein cholesterol levels were significantly reduced with nondenaturated isolated soy protein only: levels were reduced by 9.4% in the verum 1 group (P=.002) and by 4.9% in the verum 2 group (P=.107). Again, the difference between the verum groups was significant (P=.05). The results of this study confirm that supplementation with isolated soy protein can lead to significant reductions in plasma concentrations of total and low-density lipoprotein cholesterol. These reductions are significantly more pronounced with an isolated soy protein that maintains the native protein structure than with a commercially available reference isolated soy protein.

Weight reduction in obese patients with rheumatoid arthritis, with preservation of body cell mass and improvement of physical fitness.

OBJECTIVE: To reduce body weight in obese patients with rheumatoid arthritis (RA) without loss of body cell mass (BCM) and without impairment of physical performance. METHODS: Nineteen overweight RA patients were studied before, during, and after a 12-week weight reducing regime consisting of reduced dietary energy intake, supplemented with a high-protein-low-energy powder preparation, and moderate physical training. Body composition was measured by a four compartment method, which by combining determinations of total body water and total body potassium allows a distinction between the two variable components of fat free mass (FFM): BCM and extracellular water (ECW). Physical fitness was measured by a bicycle exercise test. RESULTS: Mean weight loss during the study was 4.5 kg. The patients lost 9% of their initial fat mass, 3% of initial BCM and 5% of initial ECW. Physical fitness was slightly, but significantly, improved. CONCLUSION: The regime described was successful in achieving a significant weight loss with minimal loss of BCM and maintenance of physical fitness.

Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial.

OBJECTIVE: To study whether Abacor, a product based on isolated soy protein with high and standardised levels of isoflavones and cotyledon soy fibres, was more effective in lowering total and LDL cholesterol than placebo. DESIGN: Randomised, placebo-controlled, double-blind, parallel group, single centre study. SETTING: Primary care in Joensuu, North Karelia, Finland. SUBJECTS: Subjects were screened from the patient database of the health centre; 30 were randomised to the Abacor group and 30 subjects to placebo. Eight subjects were withdrawn, six from the active group, two from the placebo group. INTERVENTION: The preparations were given as two daily liquid supplements in addition to the subjects' regular diets for 6 weeks. RESULTS: Abacor showed a statistically significant lipid-lowering effect as compared to placebo, although an unexpected reduction was seen in the placebo group. The estimated difference between active treatment and placebo was 0.25 mmol/l (95% CI 0.01, 0.50; P=0.049) for total cholesterol, corresponding to reductions of 8.3 and 5.1%, respectively. The difference in reduction of LDL-cholesterol was 0.27 mmol/l (95% CI 0.06, 0.49; P=0.014) and corresponded to a reduction of 13.2% in the active treatment group, and 8.0% in the placebo group. Abacor showed a rapid onset of effect, as compared with placebo. During a wash-out period of 4 weeks after treatment, the subjects returned to pre-treatment cholesterol levels. CONCLUSION: Added to a regular diet, Abacor significantly reduced LDL-cholesterol and total cholesterol. These beneficial effects occurred within 6 weeks of treatment.

Predictors of long-term weight reduction in obese patients after initial very-low-calorie diet.

This prospective interventional study assessed possible predictors of long-term weight loss and compared them with factors previously identified as predicting short-term variations in weight reduction after initial treatment with a very-low-calorie diet (VLCD). Eighty-two overweight patients with a body mass index of at least 27 kg/m2 were recruited from primary health-care settings into a structured weight-reduction and maintenance program. All patients used the VLCD for 8 weeks and were followed up 13.2 months later. Mean body weight decreased an average of 13.3 kg during the 8-week treatment and was still 8.6 kg below pretreatment levels after 13.2 months. Triglyceride levels were also significantly reduced. Sex, baseline weight, baseline body mass index, and age predicted 37% of the variation in short-term weight loss but had no long-term predictive value.

Compliance, clinical effects, and factors predicting weight reduction during a very low calorie diet regime.

OBJECTIVE: To study compliance, clinical effects, and factors predicting weight reduction in obese patients treated with a very low calorie diet (VLCD) regime. SETTING: A general practice in Oslo, Norway. SUBJECTS: 253 obese volunteers, aged 15-72, with a mean body mass index (BMI) of 33.4 (25-51) kg/m2. DESIGN: Open, non-comparative trial. Patients used a VLCD for eight consecutive weeks to achieve weight loss. The following were recorded every second week: weight, blood pressure, anthropometric measurements, compliance, side-effects, and patient acceptability. Blood parameters were tested before and after the trial. RESULTS: VAS-measurements showed that patients found it easy to comply with treatment, and 87.0% completed the study. Mean weight loss was 13.2 (2-33) kg. Blood pressure, serum lipids, and anthropometric measurements were significantly reduced. Side-effects were few and occurred mainly during the first two weeks of the trial. Main factors predicting weight reduction were gender, initial weight, initial BMI, and age. There was no correlation between weight loss and duration of obesity or reported number of weight reduction attempts. By VAS-measurements good acceptability of satiety and taste was recorded, and patients reported improved physical fitness and better quality of life after weight reduction.

Reduction of body mass and change in body composition on a very low calorie diet.

The quality of weight loss was estimated during a very low calorie diet (VLCD) weight-reducing regime by determining the body composition every second week using near-infra-red interactance (NII). The study was performed on 127 overweight volunteers, aged 18-72 years, who, for eight consecutive weeks, used a VLCD to lose weight. Mean weight reduction was 12.7 kg (12.6% of initial weight). Mean body fat (BF) loss was 9.5 kg (23.8% of initial BF), which constitutes 75% of the weight loss. Mean reduction in lean body mass (LBM) was 3.2 kg (5.2% of initial LBM). We found no correlation between initial body mass index (BMI) and loss of LBM, or between initial body composition and weight loss. Weight reduction observed in this study is mainly due to reduction in body fat, and the loss of LBM is considered not to be larger than acceptable.

Diet and exercise in addition to psychotherapy, in the treatment of patients suffering from eating disorders with obesity.

Treating patients with eating disorders is often a controversial issue, and obesity adds another difficulty to the treatment regimen. In this study we wanted to evaluate the outcome on body weight in patients suffering from eating disorders with obesity, by adding dietary treatment and exercise to ongoing psychotherapy. The prospective intervention study included 18 obese, female patients in primary health care and outpatient clinic with a BMI > or = 27 kg/m2 with eating disorders, nine of whom were diagnosed with bulimia according to the American Psychiatric Association. The patients had had psychotherapy for at least 2 years in a treatment programme which was chosen by a psychologist. This had had no influence on the patients' weight problem, and an additional diet and exercise regime was added to the ongoing psychotherapy through an eight-week very low calorie diet (VLCD) treatment (Nutrilett), during which the patients also participated in weekly group exercise. The patients were followed-up regularly during a 6-month period. During the 8-week VLCD treatment, which was completed by 16 patients (89%), mean body weight in the group decreased significantly from 98.8 kg to 88.6 kg. Six months after the initial treatment, average weight loss was further significantly reduced to 82.5 kg. The findings of the present study suggest that by combining ongoing psychotherapy with a well-balanced VLCD treatment and exercise it is possible to achieve substantial weight reduction in patients suffering from eating disorders with obesity.