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NCT05037591
Effect of Sea Grapes-antioxidants Extract in Obese Men : 4 Weeks Randomized-Double Blind Controlled Trial
EARLY_PHASE1 trial testing Sea grapes extract 1.68 g/70kg BW in Obesity in 70 participants. Completed in 15 September 2021.
7 September 2021
Quick facts
| Lead sponsor | State Islamic University of Sunan Kalijaga Yogyakarta |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 August 2021 |
| Primary completion | 7 September 2021 |
| Estimated completion | 15 September 2021 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Sea grapes extract 1.68 g/70kg BW — full drug profile →
- Placebo
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT05037591
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05037591 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by State Islamic University of Sunan Kalijaga Yogyakarta
- Last refreshed: 16 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05037591.
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