Effect of standardized wheat flakes breakfast provided within an energy restricted diet plan along with a controlled physical activity regimen, on weight loss among overweight subjects.
- Conditions
- Health Condition 1: null- Overweight
- Registration Number
- CTRI/2013/04/003527
- Lead Sponsor
- Spectrum Clinical Research PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1. BMI is greater than or equal to 23 and less than or equal to 30 at study entry
2. Not Allergic to milk or wheat
3. Not enrolled in the gym
4. For females only: without childbearing potential or negative HCG hormone blood test
and use of an appropriate form of contraception
5. Willing to take the wheat flakes as prescribed and sign an inform consent document
for participation in the study
1. Illness e.g. diabetes, hypertension or cholesterol problems etc. / thyroid problems
2. Participants on Medication/ special diets for weight loss
3. Gastrointestinal disorders that might cause complications or influence motility or satiety.
4. Fasting serum glucose > 126 mg/dL.
5. Conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
6. Use of medications that might affect weight or food absorption (e.g., diuretics,glucocorticoids, laxatives).
7. Alcohol consumption more than 20ml /day.
8. Currently smokes cigarettes due to the effects of nicotine on appetite
9. Pregnant and lactating women
10. Athletes or patients who do exercises every day
11. Patients suffering from Mal-Absorption Syndrome
12. Patients who are unlikely to comply with Protocol requirements e.g. uncooperative
attitude, patients who are frequent travelers, inability to return for follow up visits
13. Patient participating in any other clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of a standardized wheat flakes breakfast provided within an energy restricted diet plan along with a controlled physical activity regimen on body weight among overweight and moderate obese subjects.Timepoint: 70 Days from Baseline visit.
- Secondary Outcome Measures
Name Time Method To determine the effect of standardized wheat flakes breakfast provided within an energy restricted diet plan along with a controlled physical activity regimen on body fat, total body water and wellness parameters among overweight and moderate obese subjects.Timepoint: 70 Days from Baseline visit.