Curcumin Supplementation for the Improvement of Diabetes-related Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Group
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.
干预措施: Placebo (Dietary Supplement)
Curcumin Group
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.
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Body Weight
时间窗: 1 year
Using a standard scale, body weight in kg was assessed
Body Composition
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), body composition was assessed
Fat Mass Percentage
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage was assessed
Fat-Free Mass Percentage
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat-free mass was assessed
次要结局
- Alanine transaminase (ALT)(1 year)
- Aspartate transaminase (AST)(1 year)
- Triglyceride Levels(1 year)
- Glucose Levels(1 year)
- HDL(1 year)
- HbA1c(1 year)
- LDL(1 year)