Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers

NCT ID: NCT06188728

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-07-30

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).

Conditions

Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

Group-I comprised of 30 subjects, 15 male and 15 female. The group was assigned no intervention and kept as the control group.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

No intervention

LSM group

Group II comprised 30 subjects with the equal bifurcation of male and female. Group II was assigned the intervention of lifestyle modification (the combination of diet, physical activity, and behavior therapy)

Group Type: EXPERIMENTAL

Effect of life style modification (Diet, Behavior and physical activity)

Intervention Type: BEHAVIORAL

To assess the effect of life style modification (Diet, Behavior and physical activity) on centrally obese school teachers

PSH group

Group III comprised of 30 subjects, 15 male and 15 female. Group III was assigned the 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner.

All the subjects in the physical demonstration were briefed about the preparation and usage of psyllium husk fiber.

Group Type: EXPERIMENTAL

effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner

Intervention Type: DIETARY_SUPPLEMENT

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

LSM&PSH

Group IV comprised of 30 subjects, 15 male and 15 female. Group IV was 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

Group Type: EXPERIMENTAL

Combined effect of 10 gm Psyllium husk fiber and lifestyle modification

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: BEHAVIORAL

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

Intervention Type: COMBINATION_PRODUCT

Control

No intervention

Intervention Type: OTHER

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Agriculture, Peshawar

OTHER

Sponsor Role: collaborator

University of Peshawar

OTHER

Sponsor Role: lead

Responsible Party

Amjad Ali Bacha

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zia Din, PhD

Role: STUDY_DIRECTOR

Chairman department of human Nutrition

Locations

The University of Agriculture

Peshawar, Khyberpakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

UPeshawar

Identifier Type: -

Identifier Source: org_study_id