Metabolic Disease
Conditions
Keywords
insulin resistance,, High sensitive C reactive protein, Lipid Profile, Sleep quality analysis, Abdomens and epigastric health
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).
Interventions
DIETARY_SUPPLEMENTeffect 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
BEHAVIORALEffect 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_PRODUCTCombined 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
OTHERControl
No intervention
Sponsors
University of Agriculture, Peshawar
University of Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
comparing the intervention group with the control (intervention include either lifestyle modification, psyllium husk fiber or combined intervention of lifestyle modification and psyllium husk fiber.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 16 weeks | weight and height will be combine to calculate the BMI (kg/m\^2) |
| height (cm) | 16 weeks | Measure height in cm (centimeter) |
| Waist circumference | 16 weeks | Measure waist circumference in cm (centimeter) |
| Anthropometry | 16 weeks | weight (Kg), |
| Lipid Profile | 16 weeks | Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl. |
| 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) |
| abdomen and epigastric health | 16 weeks | Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| high sensitive C reactive protein | 16 weeks | assess the inflammation biomarkers(mg/l) |
| Insulin resistance | 16 weeks | will measure insulin resistance(Molar unit) |
Countries
Pakistan
Outcome results
None listed