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

NCT05037591 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sea grapes extract 1.68 g/70kg BW

Contains antioxidants 45.66 ± 0.55% and Caulerpin. Sea grapes are usually consumed raw without any indication of poisoning.

DRUG

Placebo

placebo lactose powder (1.68 g/70kg BW day-1).

Sponsors & Collaborators

  • State Islamic University of Sunan Kalijaga Yogyakarta

    lead OTHER

Principal Investigators

  • Fahrul Nurkolis · UIN Sunan Kalijaga Yogyakarta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2021-09-07
Completion
2021-09-15

Countries

  • Indonesia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037591 on ClinicalTrials.gov