Changes in anthropometric measurements, body composition, blood pressure, lipid profile, and testosterone in patients participating in low-energy dietary intervention

The purpose of this study was to describe changes in anthropometric measurements, body composition, blood pressure, lipid profile, and testosterone following a low–energy-density dietary intervention plus regimented supplementation program. The study design was a pre-post intervention design without a control group. Normal participants were recruited from the faculty, staff, students, and community members from a chiropractic college to participate in a 21-day weight loss program. All participants
(n equal  49; 36 women, 13 men; 31 plus and less 10.3 years of age) received freshly prepared mostly vegan meals (breakfast, lunch, and dinner) that included 1200 to 1400 daily calories (5020.8 to 5857.6 J) for the women and 1600 to 1800 (6694.4 to 7531.2 J) daily calories for the men.
Nutritional supplements containing enzymes that were intended to facilitate digestion, reduce cholesterol levels, increase metabolic rate, and mediate inflammatory processes were consumed 30 minutes before each meal. The regimented supplementation program included once daily supplementation with a green drink that contained alfalfa, wheatgrass, apple cider vinegar, and fulvic acid throughout the study period. A cleanse supplementation containing magnesium, chia, flaxseed, lemon, camu camu, cat's claw, bentonite clay, tumeric, pau darco, chanca piedra, stevia, zeolite clay, slippery elm, garlic, ginger, peppermint, aloe, citrus bioflavonoids, and fulvic acid was added before each meal during week 2. During week 3, the cleanse supplementation was replaced with probiotic and prebiotic supplementation. Multiple paired t tests detected clinically meaningful reductions in weight (minus 8.7 plus and minus  5.54 lb) (minus 3.9 plus and minus  2.5 kg), total cholesterol (minus 30.0 plus and minus  29.77 mg/dL), and low density lipoprotein cholesterol (minus 21.0 plus and minus  25.20 mg/dL). There was a pre and post intervention increase in testosterone for men (111.0 plus and minus  121.13 ng/dL). (Authors abstract)

Epidemiological evidence substantiates that consumption of low energy density carbohydrates, for example, fruits, vegetables, and whole grain products, positively impacts weight and health even though clinical trials evidence may be lagging. Recommendations for dietary interventions with probiotic and prebiotic nutritional components suggest that alleviating dysbiosis, an imbalance of intestinal bacteria and/or elevated levels of fungi, may restore the optimal microbial ecology of the gut. Probiotics and prebiotics may have significant health benefits on lipid metabolism, mineral absorption, and immune function via their beneficial influences on microbial ecology of the gut.  The purpose of the study was to describe changes in anthropometric measurements, body composition, blood pressure, lipid profile, and testosterone following a low calorie density dietary intervention plus regimented supplementation program with patient education (21minus day treatment intervention program). The selected outcome measures are some parameters used to determine if a patient meets the diagnostic criteria for metabolic syndrome, which increases the risk of cardiovascular disease, stroke, and type II diabetes.

The observational study indicated that a low calorie density dietary intervention plus regimented supplementation program including flaxseed with patient education improved weight status and lipid profiles. As discussed below, clinically meaningful differences occurred for weight loss, total cholesterol, and LDL cholesterol following the 21minus day intervention program. Improvements in weight status, total cholesterol, and LDL cholesterol decrease the risk of metabolic syndrome and associated disease states, including, but not limited to, cardiovascular disease, stroke, and type II diabetes. For men, a clinically meaningful improvement in testosterone levels was observed pre and post intervention. 
In agreement with previous literature on low calorie density diets and portion size restriction, improvements in total cholesterol and LDL cholesterol levels occurred concomitantly with weight loss after the 21minus day intervention program. The low attrition rate of 14percent with adequate adherence to the 21minus day intervention program was most likely due to the ease of consuming quality, portion controlled meals and nutritional supplements with the support of coaching and the short duration of the intervention.  Future studies need to address the potential additive effects of supplementation programs independent of dietary interventions alone, on weight loss, weight maintenance, and lipid profiles. (Editors comments)