Metabolic DiseaseNCT06188728
Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
A study testing effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner, Effect of life style modification (Diet, Behavior and physical activity) and Combined effect of 10 gm Psyllium husk fiber and lifestyle modification in people with Metabolic Disease, run by University of Peshawar at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner, Effect of life style modification (Diet, Behavior and physical activity) and Combined effect of 10 gm Psyllium husk fiber and lifestyle modification
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Sep 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Agriculture
Peshawar, Khyberpakhtunkhwa, 25000
About this study
Official title: Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the 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).
Read the 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
- Being tested
- effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner, Effect of life style modification (Diet, Behavior and physical activity), Combined effect of 10 gm Psyllium husk fiber and lifestyle modification, Control
- Keywords
- insulin resistance,, High sensitive C reactive protein, Lipid Profile, Sleep quality analysis, Abdomens and epigastric health
- Medical subject headings
- Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinnerDietary 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)Behavioural
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 modificationCombination 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
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Group-I comprised of 30 subjects, 15 male and 15 female. The group was assigned no intervention and kept as the control group. Receives: Other: Control |
| LSM group | Experimental | 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) Receives: Behavioral: Effect of life style modification (Diet, Behavior and physical activity) |
| PSH group | Experimental | 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. Receives: Dietary Supplement: effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner |
| LSM&PSH | Experimental | 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 Receives: Combination Product: Combined effect of 10 gm Psyllium husk fiber and lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
weight (Kg),
Measured: 16 weeks
Lipid Profile
Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.
Measured: 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)
Measured: 16 weeks
abdomen and epigastric health
Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health
Measured: 16 weeks
height (cm)
Measure height in cm (centimeter)
Measured: 16 weeks
Waist circumference
Measure waist circumference in cm (centimeter)
Measured: 16 weeks
BMI
weight and height will be combine to calculate the BMI (kg/m^2)
Measured: 16 weeks
Secondary outcomes (2)
Insulin resistance
will measure insulin resistance(Molar unit)
Measured: 16 weeks
high sensitive C reactive protein
assess the inflammation biomarkers(mg/l)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start7 Sep 2020
- Primary completion27 May 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparing the intervention group with the control (intervention include either lifestyle modification, psyllium husk fiber or combined intervention of lifestyle modification and psyllium husk fiber.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Agriculture, Peshawar
- Responsible party
- Principal investigator, Amjad Ali Bacha, University of Peshawar
- Investigators
- Zia Din, PhD, Study director, Chairman department of human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188728
- Sponsor's protocol ID
- UPeshawar
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: once the paper is approved and research data updated to HEC digital library
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers
- ClinicalTrials.gov ID
- NCT06188728
- Acronym / sponsor ID
- UPeshawar
- Conditions
- Metabolic Disease
- Keywords
- insulin resistance,, High sensitive C reactive protein, Lipid Profile, Sleep quality analysis, Abdomens and epigastric health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PeshawarUniversity, hospital or other
- Collaborators
- University of Agriculture, Peshawar
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- comparing the intervention group with the control (intervention include either lifestyle modification, psyllium husk fiber or combined intervention of lifestyle modification and psyllium husk fiber.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ControlGroup-I comprised of 30 subjects, 15 male and 15 female. The group was assigned no intervention and kept as the control group. |
| LSM group | Experimental | Behavioral: Effect of life style modification (Diet, Behavior and physical activity)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) |
| PSH group | Experimental | Dietary Supplement: effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinnerGroup 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 | Experimental | Combination Product: Combined effect of 10 gm Psyllium husk fiber and lifestyle modificationGroup 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinnercomparing 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 | Dietary supplement | PSH group |
| 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 | Behavioural | LSM group |
| Combined effect of 10 gm Psyllium husk fiber and lifestyle modificationTo 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 | Combination product | LSM&PSH |
| ControlNo intervention | Other | Control group |
Primary outcome
Anthropometry
Time frame: 16 weeks
weight (Kg),
Lipid Profile
Time frame: 16 weeks
Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.
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)
abdomen and epigastric health
Time frame: 16 weeks
Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health
height (cm)
Time frame: 16 weeks
Measure height in cm (centimeter)
Waist circumference
Time frame: 16 weeks
Measure waist circumference in cm (centimeter)
BMI
Time frame: 16 weeks
weight and height will be combine to calculate the BMI (kg/m^2)
2 secondary outcomes
Insulin resistance
Time frame: 16 weeks
high sensitive C reactive protein
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Yes. once the paper is approved and research data updated to HEC digital library
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zia Din, PhD study director
Chairman department of human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner, Effect of life style modification (Diet, Behavior and physical activity) and Combined effect of 10 gm Psyllium husk fiber and lifestyle modification in people with Metabolic Disease, run by University of Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.