Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers

Metabolic Disease Clinical Trial

Official title:

Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188728
• Other study ID #: UPeshawar
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2024
• Source: University of Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 30, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• 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

Behavioral:
• 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

Combination Product:
• 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

Other:
• Control
No intervention

Locations

Country	Name	City	State
Pakistan	The University of Agriculture	Peshawar	Khyberpakhtunkhwa

Sponsors (2)

Lead Sponsor	Collaborator
University of Peshawar	University of Agriculture, Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometry	weight (Kg),	16 weeks
Primary	Lipid Profile	Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.	16 weeks
Primary	Sleep quality analysis	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)	16 weeks
Primary	abdomen and epigastric health	Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health	16 weeks
Primary	height (cm)	Measure height in cm (centimeter)	16 weeks
Primary	Waist circumference	Measure waist circumference in cm (centimeter)	16 weeks
Primary	BMI	weight and height will be combine to calculate the BMI (kg/m^2)	16 weeks
Secondary	Insulin resistance	will measure insulin resistance(Molar unit)	16 weeks
Secondary	high sensitive C reactive protein	assess the inflammation biomarkers(mg/l)	16 weeks