Effect of almond supplementation on gut health and glycemic control in adults with prediabetes in rural settings of Karnataka, India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
A cluster parallel randomized control trial is designed to study the effect of almond consumption on glycemic control and gut health among the adults with prediabetes in the rural settings of Karnataka, India. Screening camps will be organized at the Chikbalapur, Kolar and Rural Bangalore taluks of Karnataka. After obtaining informed consent, a total of 178 adults aged 20-50 years with prediabetes will be enrolled from the 10 villages (considering each village as 1 unit) of these taluks. The villages will be randomly divided into control and intervention groups. The intervention group will be provided 56g of almonds as a midmorning snack whereas the counter group will be given a traditional isocaloric cereal-pulse based snack for a period of 16 weeks. The anthropometric measurements, metabolic control indicators (blood glucose levels, HbA1c, fasting insulin levels, lipid profile, liver function tests, serum creatinine, serum urea, TSH, T4 and inflammatory markers), and gut health indicators (fecal short chain fatty acids (SCFA) levels and beneficial microbiota counts) will be measured at 0,8 and 16 weeks of all the study participants. The trend of glucagon-like peptide (GLP-1) levels at 0, 10, and 30 minutes will be measured in a subgroup of 60 participants after consuming the midmorning snacks during 0 and 16th week of the intervention period. Side effects will be unlikely, but if any severe side effects due to the intervention are detected, participants will be withdrawn from the study. The study will be registered in India’s clinical trial registry. The proposed study is the first of its kind of long-term cluster randomized control trial in rural settings of India to evaluate the effect of almonds on glycemic control and gut health among adults with prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 20 years to 50 years, Both male and female, BMI 18.9 to 25 kg/m2, no nut allergies, willing to participate in the study, fasting blood glucose levels between 100 to 125 mg/dl, post-prandial blood glucose levels between 140 to 199 mg/dl, HbA1c level between 5.7 to 6.4, no comorbidities such as thyroid, diabetes, chronic kidney disease, alcoholic liver disease, or any known case of cardiovascular disease, not taking medications (steroids and beta-blockers, antibiotics) known to influence metabolism and appetite, not be a chronic alcohol dependent or chronic tobacco consumption.
排除标准
- •Pregnant women and lactating mothers, not willing to participate in the study, BMI more than 25 kg/m2, nut allergies, fasting blood glucose less than 100 mg/dL and more than 125 mg/dL, random blood glucose more than 200 mg/dL, HbA1c levels less than 5.6 and more than 6.5, other comorbidities such as thyroid, diabetes, chronic kidney disease, alcoholic liver disease, or any known case of cardiovascular disease, on medications (steroids and beta-blockers, antibiotics) known to influence metabolism and appetite, chronic illness, chronic alcohol dependent.
结局指标
主要结局
HbA1c
时间窗: 16th week
次要结局
- Glycemic control (FBS, PPBS)(Fasting Insulin, HOMA IR)
- Lipid profile (TC, TG, HDL, non-HDL, LDL, VLDL)(baseline, 8th week, 16th week)
- Blood pressure (SBP, DBP),(baseline, 8th week, 16th week)
- Inflammatory markers (IL-6, hs CRP), S creatinine, S urea(baseline, 8th week, 16th week)
- Thyroid levels (TSH, T4)(Liver function markers (SGPT, SGOT, GGT, s. bilirubin and s. protein)
- Anthropometric parameters ( body weight, body height, BMI, waist(circumference, neck circumference and hip circumference ))
- Gut microbiota composition (Lactobacilli spp & Bifidobacteria spp.)(Short chain fatty acid composition (SCFA))
- GLP-1(Baseline,Endline)