Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
- Conditions
- Metabolic Disease
- Registration Number
- NCT06188728
- Lead Sponsor
- University of Peshawar
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- School teachers aged 40-60 years (male and female)
- central obesity (where central obesity for Asians is defined as the waist circumference for men ≥ 90 cm and for women ≥ 80 cm
- with no history of any chronic disease like hypertension, Diabetes, Cardiovascular diseases, taking of any regular medication, food allergies, smoking
- physical disabilities impairing the food intake and mobility, qualified the inclusion criteria.
- Pregnant or lactating female school teachers were also excluded during screening.
- Subjects with an allergy to psyllium husk fiber, history of drug abuse, or any psychological or emotional disorder that might prevent the completion of the study were also excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anthropometry 16 weeks weight (Kg),
Lipid Profile 16 weeks Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.
abdomen and epigastric health 16 weeks Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health
Waist circumference 16 weeks Measure waist circumference in cm (centimeter)
Sleep quality analysis 16 weeks wil use Pittesburge Sleep Quality Index score (ranging from 0 to 6. where 0 reflect best sleep quality and 7 represent the worst sleep quality)
height (cm) 16 weeks Measure height in cm (centimeter)
BMI 16 weeks weight and height will be combine to calculate the BMI (kg/m\^2)
- Secondary Outcome Measures
Name Time Method Insulin resistance 16 weeks will measure insulin resistance(Molar unit)
high sensitive C reactive protein 16 weeks assess the inflammation biomarkers(mg/l)
Trial Locations
- Locations (1)
The University of Agriculture
🇵🇰Peshawar, Khyberpakhtunkhwa, Pakistan
The University of Agriculture🇵🇰Peshawar, Khyberpakhtunkhwa, Pakistan