Effect of Sea Grapes-antioxidants Extract in Obese Men : 4 Weeks Randomized-Double Blind Controlled Trial

• Status: Completed
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: Male

Summary

Doses of 150 mg/kg BW (30 mg/200g BW) sea grape extract in a previous pre-clinical trial, showed that it could improve blood glucose, total cholesterol and serum PGC-1 levels in rats fed a diet high in fat and cholesterol. In addition, you also have hepatoprotective activity (aka non-toxic) in diabetic mice. Previous research, is an in vivo (Pre-clinical) study that has not represented the benefits or efficacy of sea grape extract on variables tested in humans. Therefore, this clinical trial was conducted to support the effect of sea grape extract-antioxidant on blood glucose, total cholesterol, and PGC-1 levels in obese men for 4 weeks using a Randomized-Double Blind Controlled Trial.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State Islamic University of Sunan Kalijaga Yogyakarta

Criteria

Inclusion Criteria:

• Only individuals men who are obese (BMI ≥ 25 kg m-2) according to Asia-Pacific guidelines

• Waist Hip Ratio (WHR) ≥ 0.90 according to Asia-Pacific guidelines and

• not been diagnosed with other diseases were included in the study.

Exclusion Criteria:

• (a) significant weight variation (over 10%) in the last 3 months;

• (b) a history of cardiovascular disease including arrhythmia, heart failure, or myocardial infarction, diabetes mellitus (DM) and the use of pacemakers;

• (c) a history of conditions that may interfere with test products or inhibit their absorption such as gastrointestinal diseases (Crohn's disease) or surgeries that have been experienced (caesarean section or enterocele);

• (d) participation in other clinical trials in the last 2 months;

• (e) abnormal liver function;

• (f) a history of kidney disease (eg, acute or chronic renal failure and nephrtic syndrome);

• (g) undergo antipsychotic drug therapy within the last 2 months;

• (h) laboratory test results as well as medical or psychological conditions that may interfere with successful participation in research assessed by researchers;

• (i) a history of alcohol or substance abuse; and

• (j) allergy or hypersensitivity to any of the ingredients in the test product;

• (k) is neither a passive nor an active smoker.

• All participants give written consent before the investigation begins.