Curcumin Supplementation for the Improvement of Diabetes-related Outcomes

NCT ID: NCT06984640

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2025-02-13

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.

Conditions

Over Age 60; Prediabetes or Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

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 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laboratory for Applied Nutrition and Exercise Science (LANES)

Stillwater, Oklahoma, United States

Countries

United States

Other Identifiers

1-503351

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-23-7-STW

Identifier Type: -

Identifier Source: org_study_id