NCT04105023 (GENISTEIN) is a NA clinical trial of genistein in Metabolic Syndrome, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.

Who is sponsoring NCT04105023?

NCT04105023 is sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.

What drugs are being tested in NCT04105023?

Interventions in NCT04105023: genistein, Placebo.

What condition does NCT04105023 study?

NCT04105023 studies Metabolic Syndrome, Obesity.

Is NCT04105023 still recruiting?

NCT04105023 is currently completed. Last updated 26 September 2019.

Last reviewed 2019-09-26 · How we verify

NCT04105023: GENISTEIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Genistein Stimulates Insulin Sensitivity Through Gut Microbiota

Completed NA Last updated 26 September 2019

What this trial tests

NA trial testing genistein in Metabolic Syndrome in 45 participants. Completed in 1 December 2018.

Timeline

15 September 2013

Primary endpoint
15 December 2017

1 December 2018

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	15 September 2013
Primary completion	15 December 2017
Estimated completion	1 December 2018

Drugs / interventions tested

genistein — full drug profile →
Placebo

Conditions studied

Metabolic Syndrome — all drugs for Metabolic Syndrome →
Obesity — all drugs for Obesity →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 20 to 60, any sex, with Metabolic Syndrome or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (MetS). However, it is not known if this improvement is associated with changes in the gut microbiota. In the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with MetS. This effect will be accompanied by a modification of the gut microbiota taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.

Publications & conference data

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

Flavonoids-Natural Gifts to Promote Health and Longevity.
Fan X, Fan Z, Yang Z, Huang T, et al · · 2022 · cited 88× · PMID 35216290 · DOI 10.3390/ijms23042176
Epigenetic modifications in pancreas development, diabetes, and therapeutics.
Kaimala S, Kumar CA, Allouh MZ, Ansari SA, et al · · 2022 · cited 32× · PMID 34984701 · DOI 10.1002/med.21878
Clinical Application Potential of Small Molecules that Induce Brown Adipose Tissue Thermogenesis by Improving Fat Metabolism.
Lu KY, Primus Dass KT, Tsai SF, Chuang HM, et al · · 2020 · cited 2× · PMID 32854518 · DOI 10.1177/0963689720927394

Verify or expand the search:

Other trials of genistein

Trials testing the same drug.

NCT01126879 — Genistein in Treating Patients With Prostate Cancer · Phase 2 · terminated

Other recruiting trials for Metabolic Syndrome

Currently open trials in the same condition.

NCT07501858 — Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metaboli · recruiting
NCT06857929 — "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition" · NA · recruiting
NCT07237750 — iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss · NA · recruiting
NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07383220 — Effect of Electrical Stimulation and Exercise on Blood Flow in Patients With Resistant High Blood Pressure · NA · recruiting

Other Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran trials

Trials by the same sponsor.

NCT07004777 — Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition · NA · recruiting
NCT07018622 — Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity · Phase 2 · recruiting
NCT07507981 — Effects of Exercise in Hemodialysis · NA · completed
NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting
NCT06556836 — "Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization" · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04105023 (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 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Last refreshed: 26 September 2019

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/NCT04105023.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing