Clinical trial NCT06188728: Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
Official title: Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Keywords: insulin resistance,
High sensitive C reactive protein
Lipid Profile
Sleep quality analysis
Abdomens and epigastric health
Lead sponsor: University of Peshawar
Sponsor class: OTHER
Collaborators: name: University of Agriculture, Peshawar
First posted: 2024-01-03
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometry
timeFrame: 16 weeks
measure: Lipid Profile
timeFrame: 16 weeks
measure: Sleep quality analysis
timeFrame: 16 weeks
measure: abdomen and epigastric health
timeFrame: 16 weeks
measure: height (cm)
timeFrame: 16 weeks
measure: Waist circumference
timeFrame: 16 weeks
measure: BMI
timeFrame: 16 weeks
Secondary outcomes:
measure: Insulin resistance
timeFrame: 16 weeks
measure: high sensitive C reactive protein
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: The University of Agriculture
state: Khyberpakhtunkhwa
Study officials:
affiliation: Chairman department of human Nutrition
name: Zia Din, PhD
role: STUDY_DIRECTOR
References: