Curcumin Supplementation for the Improvement of Diabetes-related Outcomes (CUR-T2D)

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.

Study Overview

• Status: Completed
• Conditions: Over Age 60; Prediabetes or Overweight
• Intervention / Treatment: Dietary supplement: Curcumin; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Laboratory for Applied Nutrition and Exercise Science (LANES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin Group; Eligible participants were randomly assigned to receive a curcumin capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA. Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal.	Dietary supplement: Curcumin; Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. Longvida® is a trademark of Vendure Sciences, Noblesville, IN, USA.
Placebo Comparator: Placebo Group; Eligible participants were randomly assigned to receive a placebo capsule daily for 12 weeks. Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of dextrin with 0.05% tartrazine (a yellow food coloring). Treatment capsules were dispensed in bottles after baseline measurements were completed, with instructions to take one capsule per day after a meal.	Dietary supplement: Placebo; Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome Collection	Stool kits administered for fecal collection were used for gut microbiome collection	1 year

Collaborators and Investigators

• Sponsor: Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 13, 2025

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Curcumin
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Curcumin
• Other Study ID Numbers: IRB-23-7-STW; 1-503351 (Other Grant/Funding Number: Ottogi Ham Taiho Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No