se of Millets in management of obesity

Phase 2

• Conditions: Health Condition 1: E663- Overweight

• Registration Number: CTRI/2024/05/067304
• Lead Sponsor: ational institute of Ayurveda Deemed to be university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age: Participants aged between 20 and 60 years.

2. Overweight Status: Individuals with a BMI (Body Mass Index) ranging from 25 to 30 kg/m²,

indicating overweight status.

3. Health Status: Participants without any significant medical conditions, such as cardiovascular

diseases, diabetes, or metabolic disorders, that may interfere with the study outcomes.

4. Weight Stability: Individuals with stable body weight (±2 kg) for at least three months before

the study initiation.

5. Willingness to Comply: Participants willing to adhere to the prescribed millet-based dietary

intervention for the entire study duration.

6. Ability to Give Consent: Individuals capable of providing informed consent for participation

in the study.

Exclusion Criteria

1. Age and Gender: Participants having age less than 20 years or more than 60 years are Excluded.

2. BMI Status: Individuals with a BMI below 25 kg/m² (not overweight) or above 30 kg/m²

(obese).

3. Medical Conditions: Participants with a history of significant medical conditions, such as heart

disease, diabetes, renal disorders, or thyroid dysfunction.

4. Allergies or Intolerances: Participants with known allergies or intolerances to millets or any

components of the millet-based dietary intervention.

5. Pregnancy and Lactation: Pregnant or lactating individuals, as the dietary intervention may

not be suitable during these periods.

6. Participation in Other Studies: Participants currently enrolled in other clinical studies or

interventions related to weight management or nutrition.

7. Medication Use: Individuals taking medications or supplements known to affect weight or

metabolic parameters.

8. Uncontrolled Hypertension: Participants with uncontrolled hypertension (systolic blood

pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg).

9. Mental Health Concerns: Individuals with significant mental health conditions or eating

disorders that could affect dietary adherence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the change in body weight and BMI. <br/ ><br>after the millet-based dietary intervention. This outcome will assess the effectiveness of the millet <br/ ><br>diet in promoting weight reduction in participants with MedoVriddhi (overweight). Body weight <br/ ><br>will be measured at baseline (before the intervention) and at the end of the intervention period.Timepoint: at baseline to 2 nd week of Intervention

Secondary Outcome Measures

Name	Time	Method
1. Body Composition <br/ ><br>2. Metabolic Parameters <br/ ><br>3. Adherence to the Millet Diet <br/ ><br>4. Safety & Adverse Events <br/ ><br>5. Changes in Quality of Life:Timepoint: at baseline to 4-6 weeks