Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
None listed
Sponsors
National Institute of Ayurveda,Deemed to be University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Participants aged between 18 and 60 years. 2.Overweight Status: Individuals with a BMI (Body Mass Index) ranging from 23 to 29.9 kg/m , indicating overweight and preobese status. 3.Health Status: Apparently healthy individuals without any significant medical conditions requiring medication. 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 follow intervention for the entire study duration. 6.Ability to Give Consent: Individuals capable of providing informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Medical Conditions: Participants with known history of significant uncontrolled medical conditions requiring medications such as Heart disease, Hypertension, Renal disorders, endocrine disorders, diabetes mellitus, neurological disorder etc. 2. Allergies or Intolerances: Participants with known allergies of the trial drug. 3. Pregnancy and Lactation: Pregnant or lactating individuals, as the dietary intervention may not be suitable during these periods. 4. Participation in Other Studies: Participants currently enrolled in other clinical studies or interventions related to weight management or nutrition. 5. Medication Use: Individuals taking medications or supplements known to affect weight or metabolic parameters. 6.Mental Health Concerns: Individuals with significant mental health conditions or eating disorders that could affect dietary adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the change in body weight. This outcome will assess the effectiveness of basil seeds and chia seeds in promoting weight reduction in participants with sthoulya (overweight/pre-obese). Timepoint: Reduction of weight at the end of 2 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Subjective symptoms (lakshan of sthoulya) 2. Changes in BMI, weight measured in kilograms (kg) and the change in BMI, calculated as weight (kg) divided by height squared (m^2) after the dietary intervention. 3.Changes in Lipid profile (in subjects having dyslipidemia before study): (Total cholesterol, LDLcholesterol, HDL cholesterol, triglycerides). 4.Safety and Adverse Events: The occurrence of any adverse events, side effects, or safety concerns related to the dietary intervention will be recorded as secondary outcomes to ensure the intervention s safety profile. Timepoint: Improvement of Lipid profile at the end of 2 month. | — |
Countries
India
Contacts
Public ContactDr Sumit Nathani
National Institute of Ayurveda, Deemed to be University
Outcome results
None listed