A Low-Glycemic, Mediterranean Diet and Lifestyle Modification Program with Targeted Nutraceuticals Reduces Body Weight, Improves Cardiometabolic Variables and Longevity Biomarkers in Overweight Subjects: A 13-Week Observational Trial.
Study Goal
The researchers aimed to confirm the safety, tolerability, and efficacy of a calorie-restricted Mediterranean diet with targeted dietary supplementation (PROG2) in overweight and obese subjects with cardiometabolic risk factors.
Results Summary
The diet was well tolerated with 86% compliance, and common adverse effects (bloating, flatulence, constipation) were self-limiting. Subjects exhibited decreases in key cardiometabolic metrics, suggesting positive effects.
Population
Fifty healthy overweight and obese subjects with cardiometabolic risk factors.
Effective Dosage
∼68-76% of estimated calorie requirements, including protein shakes and targeted supplementation.
Duration
13 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
calorie-restricted Mediterranean diet with targeted dietary supplementation (PROG1) | neutral | safety, tolerability, and efficacy | healthy overweight and obese subjects with cardiometabolic risk factors | - | confirm the safety, tolerability, and efficacy | #1 |
modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2) | no change | tolerability | healthy overweight and obese subjects with cardiometabolic risk factors | - | was well tolerated | #2 |
modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2) | neutral | compliance | healthy overweight and obese subjects with cardiometabolic risk factors | 86% | compliance | #3 |
modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2) | neutral | adverse effects | healthy overweight and obese subjects with cardiometabolic risk factors | - | adverse effects | #4 |
modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2) | no change | adverse effects (bloating, flatulence, and constipation) | healthy overweight and obese subjects with cardiometabolic risk factors | - | were self-limiting | #5 |
modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2) | decrease | - | healthy overweight and obese subjects with cardiometabolic risk factors | - | exhibited decreases | #6 |
Among the comorbidities of high body mass index, cardiovascular disease continued to be the leading cause of death and disability globally in 2015, while type 2 diabetes remained second. The primary objectives of this observational study were to confirm the safety, tolerability, and efficacy of our calorie-restricted Mediterranean diet with targeted dietary supplementation (PROG1) using globally recognized dietary supplementation. Fifty healthy overweight and obese subjects with cardiometabolic risk factors were assigned a modified Mediterranean diet, including protein shakes and targeted supplementation (PROG2), providing ∼68-76% of subject estimated calorie requirements. Salivary nitrite was assessed weekly and key cardiometabolic metrics were recorded at baseline and weeks 9 and 13. PROG2 was well tolerated with 86% compliance. The most common adverse effects were bloating, flatulence, and constipation, which were self-limiting. Subjects exhibited decreases (