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Completed

NCT Number: NCT06984640

Curcumin Supplementation for the Improvement of Diabetes-related Outcomes

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for Applied Nutrition and Exercise Science (LANES)

Stillwater, Oklahoma, 74078, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Body Weight

    Time frame: 1 year

    Using a standard scale, body weight in kg was assessed

  2. Body Composition

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed

  3. Fat Mass Percentage

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed

  4. Fat-Free Mass Percentage

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed

Secondary outcomes

  1. Triglyceride Levels

    Time frame: 1 year

    Blood draw followed by a Piccolo scan analyzed Triglyceride levels in the blood

  2. Glucose Levels

    Time frame: 1 year

    Blood draw followed by a Piccolo scan analyzed glucose in the blood

  3. HDL

    Time frame: 1 year

    Blood draw followed by a Piccolo scan analyzed HDL in the blood

  4. LDL

    Time frame: 1 year

    Piccolo scan analyzed LDL in the blood

  5. HbA1c

    Time frame: 1 year

    Piccolo scan analyzed HbA1c in the blood

  6. Alanine transaminase (ALT)

    Time frame: 1 year

    Blood draw followed by a Piccolo scan analyzed ALT in the blood

  7. Aspartate transaminase (AST)

    Time frame: 1 year

    Blood draw followed by a Piccolo scan analyzed AST in the blood

Other outcomes

  1. Gut Microbiome Collection

    Time frame: 1 year

    Stool kits administered for fecal collection were used for gut microbiome collection

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Acronym: CUR-T2D

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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