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To study the effect of Millet consumption and Cinnamon supplementation on blood glucose levels in prediabetics in urban slums of Pune city

Effect of Millet consumption and Cinnamon supplementation on glycaemic control amongst prediabetics residing in urban slums of Western Maharashtra: A three arm community based cluster randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083744
Enrollment
523
Registered
2025-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: R730- Abnormal glucose

Interventions

Intervention1: Millet (Sorghum), 250 grams/day for 6 months: Millet sorghum (Jawari flour) 250 gram per day for 6 months. The sorghum (jawari flour) can be consumed in the form of Indian bread (bhaka
it will have a white-coloured body capsule The participants will be given a bottle of 60 capsules once a month. The participants will take 1 oral capsule (500 mg) before breakfast daily for 6 months.

Sponsors

Central Research and Publication Unit
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For Millets intervention-Patients who can eat sorghum daily For cinnamon intervention- Patients who can ready to consume Cinnamon daily for 6 months

Exclusion criteria

Exclusion criteria: Known Diabetic patients Patients with a history of an allergy to cinnamon and sorghum Patients who are eating Sorghum and cinnamon daily Taking medications affecting glucose tolerance (glucocorticoids, anti-psychotic drugs and anti-retroviral drugs).) Daily alcohol consumption Patients with diagnosed alcoholic liver disease (ALD), cirrhosis Patients with renal failure Patients with symptoms suggestive of peptic ulcer disease and those with a past history of peptic ulceration Patients with cardiac, liver, or respiratory failure Patients with bleeding disorders and who are taking coumarin derivatives (e.g., warfarin) Patients with any malignancy Pregnancy and Lactation Patient who is planning for pregnancy in the study period Any condition that, in the opinion of the primary investigator, would contraindicate the patient s participation.

Design outcomes

Primary

MeasureTime frame
HBA1c (Glycosylated Hemoglobin)Timepoint: At Baseline (Start of study) At 3 months (Mid of study) and At 6 months (End of study)

Secondary

MeasureTime frame
1. Cardiovascular disease risk- which includes Anthropometric parameters such as height, body weight, waist & hip circumferences, systolic & diastolic blood pressure readings, Biochemical measurements like Total cholesterol (mg/dL) Triglycerides (mg/dL) High-density lipoprotein (mg/dL) Low-density lipoprotein (mg/dL) 2. Obstructive sleep apnoea-The Berlin Questionnaire will be used to assess each participant s Obstructive Sleep Apnea risk status 3. Sleep Quality- Sleep quality will be assessed by using Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire for the assessment of sleep patterns & their predictors Timepoint: At Baseline (Start of the study) & At 6 months (End of the study)

Countries

India

Contacts

Public ContactDr Sudhanshu Ashok Mahajan

Professor and Head of Central Research and Publication Unit

jayashree.gothankar@bharatividyapeeth.edu9503785948

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026