Effect of almond consumption on gut health and glycemic control in adults with prediabetes
- Registration Number
- CTRI/2023/03/050421
- Lead Sponsor
- Almond Board of California
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1cTimepoint: 16th week
- Secondary Outcome Measures
Name Time Method Anthropometric parameters ( body weight, body height, BMI, waist <br/ ><br>circumference, neck circumference and hip circumference ) <br/ ><br>Dietary assessment (24 hr dietary recall) <br/ ><br>Physical activity assessment (PAL levels)Timepoint: baseline, 8th week, 16th week;Blood pressure (SBP, DBP),Timepoint: baseline, 8th week, 16th week;GLP-1Timepoint: Baseline,Endline;Glycemic control (FBS, PPBS) <br/ ><br>Fasting Insulin, HOMA IR <br/ ><br>Timepoint: baseline, 8th week, 16th week <br/ ><br>;Gut microbiota composition (Lactobacilli spp & Bifidobacteria spp.) <br/ ><br>Short chain fatty acid composition (SCFA)Timepoint: baseline, 8th week, 16th week;Inflammatory markers (IL-6, hs CRP), S creatinine, S ureaTimepoint: baseline, 8th week, 16th week;Lipid profile (TC, TG, HDL, non-HDL, LDL, VLDL)Timepoint: baseline, 8th week, 16th week;Thyroid levels (TSH, T4) <br/ ><br>Liver function markers (SGPT, SGOT, GGT, s. bilirubin and s. protein <br/ ><br>albumin) <br/ ><br>Timepoint: baseline, 8th week, 16th week