Meal replacement based on Human Ration modulates metabolic risk factors during body weight loss: a randomized controlled trial.
Study Goal
The researchers aimed to determine whether a phytochemical-rich nutritional supplement, when combined with a hypocaloric diet, could improve metabolic risk parameters in obese women compared to caloric restriction alone.
Results Summary
The supplement did not enhance weight loss beyond caloric restriction alone but improved central lipolysis (reduced waist circumference and gynoid fat) and increased HDL-c levels. Both interventions modestly reduced body weight, BMI, and HOMA-IR.
Population
Obese women (BMI 28.72 ± 2.87 kg/m², body fat 40.52 ± 3.75%, age 35.04 ± 5.6 years).
Effective Dosage
Not specified (consumed as a breakfast substitute).
Duration
Two 5-week periods with a 1-week washout.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | decrease | body weight | obese women | -0.77 ± 1.3 kg | favorably modulated | #1 |
hypocaloric diet and control drink consumption (CR) | decrease | body weight | obese women | -0.74 ± 1.27 kg | favorably modulated | #2 |
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | decrease | body mass index (BMI) | obese women | -0.30 ± 0.52 kg/m² | favorably modulated | #3 |
hypocaloric diet and control drink consumption (CR) | decrease | body mass index (BMI) | obese women | -0.27 ± 0.51 kg/m² | favorably modulated | #4 |
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | decrease | HOMA-IR | obese women | -0.41 ± 0.83 | favorably modulated | #5 |
hypocaloric diet and control drink consumption (CR) | decrease | HOMA-IR | obese women | -0.35 ± 0.82 | favorably modulated | #6 |
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | decrease | waist circumference | obese women | -2.54 ± 2.74 cm | reduced | #7 |
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | decrease | gynoid fat | obese women | -0.264 ± 0.28 g | reduced | #8 |
hypocaloric diet and drink containing 'Human Ration' (HR) consumption (CRHR) | increase | HDL-c levels | obese women | 0.08 ± 0.15 mmol/l | increased | #9 |
nutritional supplement rich in phytochemicals as a breakfast substitute | no change | weight reduction | obese women | - | had no additional effect | #10 |
nutritional supplement rich in phytochemicals as a breakfast substitute | increase | central lipolysis | obese women | - | increased | #11 |
nutritional supplement rich in phytochemicals as a breakfast substitute | increase | lipoprotein profile | obese women | - | improved | #12 |
PURPOSE: A meal replacement may be an effective strategy in the management of obesity to increase antioxidant intake, attenuating oxidative stress and inflammation. In the present study, we investigated the efficacy of a new nutritional supplement to reduce metabolic risk parameters in obese women. METHODS: In a randomized controlled crossover study (2 × 2), 22 women (percentage body fat 40.52 ± 3.75%; body mass index-BMI 28.72 ± 2.87 kg/m²; 35.04 ± 5.6 years old) were allocated into two treatments: hypocaloric diet and drink containing "Human Ration" (HR) consumption (CRHR), and hypocaloric diet and control drink consumption (CR). The study consisted of 2 periods of 5 weeks with 1 week of washout in two orders (CR → CRHR and CRHR → CR). Caloric restriction was 15%, based on estimated energy requirement. Anthropometric, clinical and metabolic risk parameters were assessed at baseline and at the end of each period. RESULTS: Some metabolic risk factors were favorably modulated in both interventions: reduction in body weight (CR -0.74 ± 1.27 kg; p = 0.01; CRHR -0.77 ± 1.3 kg; p = 0.02), body mass index (BMI) (CR -0.27 ± 0.51 kg/m²; p = 0.02; CRHR -0.30 ± 0.52 kg/m²; p = 0.01) and HOMA-IR (CR -0.35 ± 0.82; p = 0.02, CRHR -0.41 ± 0.83; p = 0.03). However, CRHR reduced waist circumference (-2.54 ± 2.74 cm; p < 0.01) and gynoid fat (-0.264 ± 0.28 g; p < 0.01), and increased HDL-c levels (0.08 ± 0.15 mmol/l; p = 0.04). CONCLUSION: Associated with hypocaloric diet, the intake of a nutritional supplement rich in phytochemicals as a breakfast substitute for 5 weeks had no additional effect on weight reduction than caloric restriction alone, but increased central lipolysis and improved the lipoprotein profile.