Trials / Completed
CompletedNCT06188728
Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- University of Peshawar · Academic / Other
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
A group of 120 school teachers (male=60, female=60) was divided into four subgroups for sixteen weeks of an interventional study. One group was kept in control while the other three groups were assigned intervention. One group was assigned intervention of lifestyle modification (LSM), the other group assigned the intervention of 5 gm psyllium husk fiber (PSH) two times a day, and the third group assigned the combined intervention of LSM \& PSH. Each group comprised of 30 subjects with equal gender bifurcation (15 male and 15 female).
Detailed description
The school teachers who qualified for the initial screening and eligibility criteria were formally enrolled in the intervention. An informed consent form was signed by each subject explaining the data privacy and the subject's obligation. School teachers with lifestyle modification were advised to adhere to three major components, i.e., diet modification, physical activity, and behavioral therapy. subjects in the psyllium husk fiber group were assigned the consumption of 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner. subjects in the combined group of psyllium husk fiber and physical activity were assigned both the intervention of psyllium husk fiber @ 5gm two times a day, 30 minutes before breakfast and dinner in swelled gel form with the combination of lifestyle modification, while one group remained as control (without any intervention).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner | comparing the effect of psyllium husk fiber and lifestyle modification alone with the combined effect of psyllium husk fiber on metabolic health of centrally obese school teachers |
| BEHAVIORAL | Effect of life style modification (Diet, Behavior and physical activity) | To assess the effect of life style modification (Diet, Behavior and physical activity) on centrally obese school teachers |
| COMBINATION_PRODUCT | Combined effect of 10 gm Psyllium husk fiber and lifestyle modification | To evaluate the combined effect of 10 gm psyllium husk fiber in gel form, 30 minutes before breakfast and dinner along with dietary, behavioral and physical activity modification on centrally obese school teachers |
| OTHER | Control | No intervention |
Timeline
- Start date
- 2020-09-07
- Primary completion
- 2021-05-27
- Completion
- 2021-07-30
- First posted
- 2024-01-03
- Last updated
- 2024-01-05
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT06188728. Inclusion in this directory is not an endorsement.