Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial.

2025-06-19
Nutrients 17(12)
- Victoria Martinez
- Kay McAngus
- Broderick L Dickerson
- Megan Leonard
- Elena Chavez
- Jisun Chun
- Megan Lewis
- Dante Xing
- Drew E Gonzalez
- Choongsung Yoo
- Joungbo Ko
- Heather Rhodes
- Hudson Lee
- Ryan J Sowinski
- Christopher J Rasmussen
- Richard B Kreider

PubMed: 40573153
DOI: 10.3390/nu17122042

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 166 sedentary men and women with at least two markers of metabolic syndrome
Methods: randomized, placebo-controlled, parallel-arm, and repeated-measure intervention study; 12-week exercise program (supervised resistance and endurance exercise 3 days/week with walking 10,000 steps/day on non-training days) and dietary restriction (-5 kcals/kg/d); double-blind supplementation of placebo, PE-500, PE-1000, Cr-400, or Cr-800 once daily for 12 weeks
Blinding: Double-blind
Duration: 12 weeks
Funding: Unclear

Rigorous Journal

Background: Exercise and nutritional interventions are often recommended to help manage risk related to metabolic syndrome (MetSyn). The co-ingestion of Phyllanthus emblica (PE) with trivalent chromium (Cr) has been purported to improve the bioavailability of chromium and enhance endothelial function, reduce platelet aggregation, and help manage blood glucose as well as lipid levels. Shilajit (SJ) has been reported to have anti-inflammatory, adaptogenic, immunomodulatory, and lipid-lowering properties. This study evaluated whether dietary supplementation with Cr, PE, and SJ, or PE alone, during an exercise and diet intervention may help individuals with risk factors to MetSyn experience greater benefits. Methods: In total, 166 sedentary men and women with at least two markers of metabolic syndrome participated in a randomized, placebo-controlled, parallel-arm, and repeated-measure intervention study, of which 109 completed the study (48.6 ± 10 yrs., 34.2 ± 6 kg/m², 41.3 ± 7% fat). All volunteers participated in a 12-week exercise program (supervised resistance and endurance exercise 3 days/week with walking 10,000 steps/day on non-training days) and were instructed to reduce energy intake by -5 kcals/kg/d. Participants were matched by age, sex, BMI, and body mass for the double-blind and randomized supplementation of a placebo (PLA), 500 mg of PE (PE-500), 1000 mg/d of PE (PE-1000), 400 µg of trivalent chromium (Cr) with 6 mg of PE and 6 mg of SJ (Cr-400), or 800 µg of trivalent chromium with 12 mg of PE and 12 mg of SJ (Cr-800) once a day for 12 weeks. Data were obtained at 0, 6, and 12 weeks of supplementation, and analyzed using general linear model multivariate and univariate analyses with repeated measures, pairwise comparisons, and mean changes from the baseline with 95% confidence intervals (CIs). Results: Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation improved pulse wave velocity, flow-mediated dilation, platelet aggregation, insulin sensitivity, and blood lipid profiles while promoting more optimal changes in body composition, strength, and aerobic capacity. Differences among groups were more consistently seen at 6 weeks rather than 12 weeks. While some benefits were seen at both dosages, greater benefits were more consistently observed with PE-1000 and Cr-800 ingestion. Conclusions: The results suggest that PE and Cr with PE and SJ supplementation may enhance some exercise- and diet-induced changes in markers of health in overweight individuals with at least two risk factors to MetSyn. Registered clinical trial #NCT06641596.

Research Insights

Shilajit→Improved Body Composition
Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation ... promoted more optimal changes in body composition
Effect
Beneficial
Effect size
Moderate
Dose
6 mg of SJ (in Cr-400), 12 mg of SJ (in Cr-800)
Shilajit→Improved Insulin Sensitivity
Compared to PLA responses, there was some evidence (p < 0.05 or approaching significance, p > 0.05 to p < 0.10) that PE and/or Cr with PE and SJ supplementation improved ... insulin sensitivity
Effect
Beneficial
Effect size
Moderate
Dose
6 mg of SJ (in Cr-400), 12 mg of SJ (in Cr-800)