Curcumin Supplementation for the Improvement of Diabetes-related Outcomes

NCT06984640 | Completed

• 2 other identifiers: IRB-23-7-STW1-503351
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.Curcumin supplementation will improve glycemic control in older adults with pre-diabetic conditions over a 12-week period.
2. 2.Curcumin supplementation will beneficially alter gut microbiota composition and diversity, which is associated with improved metabolic outcomes in older adults with pre-diabetes.
3. 3.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

Keywords

Curcumin; Aging

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Triglyceride Levels

  1 year

• Glucose Levels

  1 year

• HDL

  1 year

• LDL

  1 year

• HbA1c

  1 year

Other Outcomes (1)

• Gut Microbiome Collection

  1 year

Study Arms (2)

Curcumin Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Curcumin 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.

Curcumin Group

Placebo DIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Laboratory for Applied Nutrition and Exercise Science (LANES)

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Prediabetic State; Overweight

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Age: Over 60 years (male and female)-preference is with pre-diabetic condition * Participants: around 20-25 per group (placebo and treatment) \<Screening method\> * Recruiting * Initial visit: questionnaire and fasting glucose test * Selecting participants: 20-25 placebo group / 20-25 curcumin supplement group * Criteria for selection * A1C level: 5.7-6.4% or * Fasting blood glucose level: 100-125 mg/dL * BMI ≥ 26-30 (≥ 30 will be considered if numbers are not enough) \* Exclusion criteria * A preexisting cardiometabolic condition such as diabetes * Liver disease * Dementia * Tobacco use within one year prior to the study * Use of medications targeting diabetes or blood lipids

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: March 16, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 13, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)