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NCT05037591

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

Completed EARLY_PHASE1 Last updated 16 September 2021
What this trial tests

EARLY_PHASE1 trial testing Sea grapes extract 1.68 g/70kg BW in Obesity in 70 participants. Completed in 15 September 2021.

Timeline
1 August 2021
Primary endpoint
7 September 2021
15 September 2021

Quick facts

Lead sponsorState Islamic University of Sunan Kalijaga Yogyakarta
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment70
Start date1 August 2021
Primary completion7 September 2021
Estimated completion15 September 2021
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

State Islamic University of Sunan Kalijaga Yogyakarta

Who can join

Adults 19 to 60, male only, with Obesity or Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Metabolomic Assay, Computational Screening, and Pharmacological Evaluation of <i>Caulerpa racemosa</i> as an Anti-obesity With Anti-aging by Altering Lipid Profile and Peroxisome Proliferator-Activated Receptor-γ Coactivator 1-α Levels.
    Permatasari HK, Nurkolis F, Hardinsyah H, Taslim NA, et al · · 2022 · cited 19× · PMID 35911110 · DOI 10.3389/fnut.2022.939073
  2. Could Natural Products Help in the Control of Obesity? Current Insights and Future Perspectives.
    Park J, Nurkolis F, Won H, Yang J, et al · · 2023 · cited 6× · PMID 37764380 · DOI 10.3390/molecules28186604

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