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| ID | Type | Description | Link |
|---|---|---|---|
| 1-503351 | Other Grant/Funding Number | Ottogi Ham Taiho Foundation |
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The goal of this clinical trial is to learn about, test, and compare health outcomes of curcumin supplementation (400 mg). Two primary hypotheses are:
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.
Curcumin supplementation will beneficially alter gut microbiota composition and diversity, which is associated with improved metabolic outcomes in older adults with pre-diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride Levels | Blood draw followed by a Piccolo scan analyzed Triglyceride levels in the blood | 1 year |
| Glucose Levels | Blood draw followed by a Piccolo scan analyzed glucose in the blood |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiome Collection | Stool kits administered for fecal collection were used for gut microbiome collection | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Applied Nutrition and Exercise Science (LANES) | Stillwater | Oklahoma | 74078 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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<Screening method>
Recruiting
Initial visit: questionnaire and fasting glucose test
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
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| Placebo | Dietary Supplement | Each capsule contained 400 mg of a patented lipophilic matrix, delivering 80 mg of curcumin. |
|
| 1 year |
| HDL | Blood draw followed by a Piccolo scan analyzed HDL in the blood | 1 year |
| LDL | Piccolo scan analyzed LDL in the blood | 1 year |
| HbA1c | Piccolo scan analyzed HbA1c in the blood | 1 year |
| Alanine transaminase (ALT) | Blood draw followed by a Piccolo scan analyzed ALT in the blood | 1 year |
| Aspartate transaminase (AST) | Blood draw followed by a Piccolo scan analyzed AST in the blood | 1 year |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |