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Effect of almond consumption on gut health and glycemic control in adults with prediabetes

Effect of almond supplementation on gut health and glycemic control in adults with prediabetes in rural settings of Karnataka, India

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050421
Enrollment
178
Registered
2023-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Almonds: - Food intervention: Almonds - Amount to be consumed per day: 56grams - Duration: 16 weeks - Route of administration: oral Control Intervention1: Traditional cereal pulse based

Sponsors

Almond Board of California
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
HbA1cTimepoint: 16th week

Secondary

MeasureTime frame
Anthropometric parameters ( body weight, body height, BMI, waist circumference, neck circumference and hip circumference ) Dietary assessment (24 hr dietary recall) 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) Fasting Insulin, HOMA IR Timepoint: baseline, 8th week, 16th week ;Gut microbiota composition (Lactobacilli spp & Bifidobacteria spp.) 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) Liver function markers (SGPT, SGOT, GGT, s. bilirubin and s. protein albumin) Timepoint: baseline, 8th week, 16th week

Countries

India

Contacts

Public ContactDr Pramila Kalra

Ramaiah International Centre for Public Health Innovations

ruchi.vaidya@ramaiahgroup.org07227983849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 10, 2026