Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 3, 2024
CompletedJanuary 5, 2024
January 1, 2024
9 months
March 14, 2022
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Anthropometry
weight (Kg),
16 weeks
Lipid Profile
Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.
16 weeks
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
abdomen and epigastric health
Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health
16 weeks
height (cm)
Measure height in cm (centimeter)
16 weeks
Waist circumference
Measure waist circumference in cm (centimeter)
16 weeks
BMI
weight and height will be combine to calculate the BMI (kg/m\^2)
16 weeks
Secondary Outcomes (2)
Insulin resistance
16 weeks
high sensitive C reactive protein
16 weeks
Study Arms (4)
Control group
PLACEBO COMPARATORGroup-I comprised of 30 subjects, 15 male and 15 female. The group was assigned no intervention and kept as the control group.
LSM group
EXPERIMENTALGroup 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)
PSH group
EXPERIMENTALGroup 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.
LSM&PSH
EXPERIMENTALGroup 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
Interventions
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
To assess the effect of life style modification (Diet, Behavior and physical activity) on centrally obese school teachers
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Peshawarlead
- University of Agriculture, Peshawarcollaborator
Study Sites (1)
The University of Agriculture
Peshawar, Khyberpakhtunkhwa, 25000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zia Din, PhD
Chairman department of human Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 14, 2022
First Posted
January 3, 2024
Study Start
September 7, 2020
Primary Completion
May 27, 2021
Study Completion
July 30, 2021
Last Updated
January 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- once the research paper published
- Access Criteria
- through google scholar
once the paper is approved and research data updated to HEC digital library