Background/Objectives
Sea grapes are harvested intensively because it considered as important source of macronutrients-micronutrients, especially in Southeast Asia as the main source of traditional diets(Reference Chen1,Reference Kuswari2) . Therefore, this clinical trial was conducted to evaluate the effect of sea grapes extract on lipid profile and PGC-1α levels in obese men for 4 weeks with a randomized-double blind controlled trial.
Methods
The study was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A random number between 1 and 70 was generated for each subject and registered participants were scheduled for their first visit and randomly assigned dose 1.68 g/70 kg BB/day to the placebo (A; n = 35) or sea grape extract group (B; n = 35). Sea grape extract/placebo tablets/capsules were given to participants every 1 week (1 day of consumption per oral) 15 Minutes before eating. Only individuals men who are obese (BMI≥25 kg.m-2) and Waist Hip Ratio (WHR)≥0.90 according to Asia-Pacific guidelines, not been diagnosed with other diseases were included in the study. An Independent T-test (SPSS 26) CI 95% was used to analyze the difference between characteristics at the baseline and 4 weeks of intervention. Ethical approval from the RSUP Prof. Dr. RD. Kandou No.142/EC/KEPK-KANDOU/VIII/2021 and ClinicalTrials.gov NCT05037591. Sea grape extract capsules contain antioxidant activity 45.66 ± 0.55%.
Results
A total of 69 participants (35 sea grapes extract and 34 placebo group). There was no significant differences (p > 0.05) from each variable at baseline (Group A to B). After 4 weeks of intervention, there was a significant decreases in blood glucoes, total cholesterol, LDL, triglycerides, waist circumference, waist-hip ratio and body weight (p < 0.05); PGC-1α and HDL increases significant (p = 0.000), respectively in group B compared to the group A. Anova's One-Way test of physical activity, food and water intake from 0–4 weeks showed no change (p > 0.05; which means controlled). No clinically significant changes in any safety parameter were observed (safe).
Discussion / Conclusion
Sea grapes extract has benefits in improving lipid profile, waist circumference, waist-hip ratio, and body weight as well as improving serum PGC-1α. These results suggest that sea grapes extract supplementation may be effective for treating obese individuals as a functional anti-obesity and anti-aging food supplement.
Disclosure of Interest
None Declared
