Over Age 60, Prediabetes or Overweight
Conditions
Keywords
Curcumin, Aging
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
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.
DIETARY_SUPPLEMENTPlacebo
Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin.
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
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
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat-Free Mass Percentage | 1 year | Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed |
| Body Weight | 1 year | Using a standard scale, body weight in kg was assessed |
| Body Composition | 1 year | Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed |
| Fat Mass Percentage | 1 year | Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL | 1 year | Piccolo scan analyzed LDL in the blood |
| HbA1c | 1 year | Piccolo scan analyzed HbA1c in the blood |
| Aspartate transaminase (AST) | 1 year | Blood draw followed by a Piccolo scan analyzed AST in the blood |
| Alanine transaminase (ALT) | 1 year | Blood draw followed by a Piccolo scan analyzed ALT in the blood |
| Triglyceride Levels | 1 year | Blood draw followed by a Piccolo scan analyzed Triglyceride levels in the blood |
| Glucose Levels | 1 year | Blood draw followed by a Piccolo scan analyzed glucose in the blood |
| HDL | 1 year | Blood draw followed by a Piccolo scan analyzed HDL in the blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome Collection | 1 year | Stool kits administered for fecal collection were used for gut microbiome collection |
Countries
United States
Outcome results
None listed