Clinical trial NCT06984640: Curcumin Supplementation for the Improvement of Diabetes-related Outcomes
Official title: Curcumin Supplementation for the Improvement of Diabetes-related Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Over Age 60
Prediabetes or Overweight
Keywords: Curcumin
Aging
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: * 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
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Body Weight
timeFrame: 1 year
measure: Body Composition
timeFrame: 1 year
measure: Fat Mass Percentage
timeFrame: 1 year
measure: Fat-Free Mass Percentage
timeFrame: 1 year
Secondary outcomes:
measure: Triglyceride Levels
timeFrame: 1 year
measure: Glucose Levels
timeFrame: 1 year
measure: HDL
timeFrame: 1 year
measure: LDL
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: Alanine transaminase (ALT)
timeFrame: 1 year
measure: Aspartate transaminase (AST)
timeFrame: 1 year
Other outcomes:
measure: Gut Microbiome Collection
timeFrame: 1 year
Locations:
city: Stillwater
country: United States
facility: Laboratory for Applied Nutrition and Exercise Science (LANES)
state: Oklahoma
Study officials:
References: