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Completed

NCT Number: NCT06188728

Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers

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).

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Agriculture

Peshawar, Khyberpakhtunkhwa, 25000, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Behavioral

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

Combined effect of 10 gm Psyllium husk fiber and lifestyle modification

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

Control

Other

No intervention

Primary outcomes

  1. Anthropometry

    Time frame: 16 weeks

    weight (Kg),

  2. Lipid Profile

    Time frame: 16 weeks

    Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.

  3. Sleep quality analysis

    Time frame: 16 weeks

    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)

  4. abdomen and epigastric health

    Time frame: 16 weeks

    Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health

  5. height (cm)

    Time frame: 16 weeks

    Measure height in cm (centimeter)

  6. Waist circumference

    Time frame: 16 weeks

    Measure waist circumference in cm (centimeter)

  7. BMI

    Time frame: 16 weeks

    weight and height will be combine to calculate the BMI (kg/m^2)

Secondary outcomes

  1. Insulin resistance

    Time frame: 16 weeks

    will measure insulin resistance(Molar unit)

  2. high sensitive C reactive protein

    Time frame: 16 weeks

    assess the inflammation biomarkers(mg/l)

Sponsors and collaborators

Lead sponsor

University of Peshawar

Other

Collaborators

  • University of Agriculture, Peshawar

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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