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.

A Prospective, Open Label study to evaluate the 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. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/04/003527

Enrollment

Registered

2013-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Overweight

Interventions

Intervention1: Milk + wheat flakes + nut mix + fruits: Subjects will be served standardized wheat flakes with milk and fruits as a breakfast. They will be monitored everyday for intake of wheat flakes

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactMr Sushil Singh

Spectrum Clinical Research

ssingh@spectrumcr.com02240645100

Outcome results

None listed

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