Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers

University of Peshawar

Status: Completed

Conditions: Metabolic Disease

Treatments: Combination Product: Combined effect of 10 gm Psyllium husk fiber and lifestyle modification; Dietary Supplement: effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner; Behavioral: Effect of life style modification (Diet, Behavior and physical activity); Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06188728

UPeshawar

Details and patient eligibility

About

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).

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Control

LSM group

Experimental group

Description:

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)

Treatment:

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

PSH group

Experimental group

Description:

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.

Treatment:

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

LSM&PSH

Experimental group

Description:

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

Treatment:

Combination Product: Combined effect of 10 gm Psyllium husk fiber and lifestyle modification