Curcumin Supplementation for the Improvement of Diabetes-related Outcomes

Not Applicable

Completed

• Conditions: Over Age 60; Prediabetes or Overweight

• Registration Number: NCT06984640
• Lead Sponsor: Oklahoma State University

Brief Summary

The goal of this clinical trial is to learn about, test, and compare health outcomes of curcumin supplementation (400 mg). Two primary hypotheses are:

1. Curcumin supplementation will improve glycemic control in older adults with pre-diabetic conditions over a 12-week period.

\* Rationale: Curcumin has been shown to enhance insulin sensitivity, reduce fasting blood glucose, and lower HbA1c levels in preclinical and clinical studies. This hypothesis will be tested by measuring changes in fasting glucose, insulin levels, and diabetic biomarkers from baseline (Week 0) to Week 12.

2. Curcumin supplementation will beneficially alter gut microbiota composition and diversity, which is associated with improved metabolic outcomes in older adults with pre-diabetes.

* Rationale: Curcumin is known to possess prebiotic-like properties and can influence gut microbial populations. By analyzing stool samples using metagenomic sequencing, this hypothesis will evaluate whether curcumin intake leads to increased abundance of beneficial bacteria (e.g., Akkermansia, Faecalibacterium) and decreased pathogenic taxa, alongside improved metabolic markers.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-16
• Primary Completion: 2024-02-14
• Study Completion: 2025-02-13
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• To be eligible, participants were required to meet at least one of the following criteria: a) Prediabetes, defined as a fasting blood glucose level of 100-125 mg/dL or an HbA1c of 5.7-6.4%, or b) A body mass index (BMI) ≥25.

Exclusion Criteria

• a) A preexisting cardiometabolic condition such as diabetes, b) Liver disease, c) De-mentia, d) Tobacco use within one year prior to the study, and e) Use of medications targeting diabetes or blood lipids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Body Weight	1 year	Using a standard scale, body weight in kg was assessed
Body Composition	1 year	Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed
Fat Mass Percentage	1 year	Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed
Fat-Free Mass Percentage	1 year	Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed

Secondary Outcome Measures

Name	Time	Method
Alanine transaminase (ALT)	1 year	Blood draw followed by a Piccolo scan analyzed ALT in the blood
Aspartate transaminase (AST)	1 year	Blood draw followed by a Piccolo scan analyzed AST in the blood
Triglyceride Levels	1 year	Blood draw followed by a Piccolo scan analyzed Triglyceride levels in the blood
Glucose Levels	1 year	Blood draw followed by a Piccolo scan analyzed glucose in the blood
HDL	1 year	Blood draw followed by a Piccolo scan analyzed HDL in the blood
HbA1c	1 year	Piccolo scan analyzed HbA1c in the blood
LDL	1 year	Piccolo scan analyzed LDL in the blood

Trial Locations

Locations (1)

Laboratory for Applied Nutrition and Exercise Science (LANES); 🇺🇸 Stillwater, Oklahoma, United States