Effect of Fenugreek and Cumin Powder on Overweight and Obese People

July 7, 2024 updated by: Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan

Effect of Fenugreek and Cumin Powder on Anthropometric Indices of Overweight and Obese Adults

The objective of this study is to investigate the effect of fenugreek and cumin powder on the anthropometric indices of overweight and obese adults aged 18-30 years. This study design intends to answer following question:

Will fenugreek and cumin powder mixture result in change of anthropometric measurements {Body Mass Index[BMI], Waist-Hip Ratio, Fat Mass

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is a chronic disorder of carbohydrate and lipid metabolism and is characterized by an increased fat deposition in adipose tissue and other internal organs .

Obesity leads to the development of insulin resistance, type-2 diabetes, coronary heart disease, cancer, respiratory disease, and osteoarthritis. The World Obesity Atlas 2022 predicts that one billion people globally, including 1 in 5 women and 1 in 7 men, will be living with obesity by 2030.

Pakistan ranks tenth out of 188 countries, with 50% of population overweight or obese Several studies have investigated the effect of fenugreek and cumin supplementation on anthropometric measures but the findings have been inconsistent. Only few studies directly focused on powder supplementation. The study aims to investigate the effect of fenugreek and cumin powder supplementation on body measurements for weight loss. This will help in developing a rather inexpensive, herbal mixture for weight loss.

Galactomannan present in fenugreek capture and excrete sugars from body before it moves in the blood, this causes the loss of weight The percent gain in body weight was significantly low in groups supplemented with fenugreek Cumin improves anthropometric indices in overweight. Cumin powder reduced weight, Body Mass Index[BMI], waist circumference, fat mass and percentage significantly.

This study consists of following phases Phase 1: Fenugreek and cumin powder preparation Phase 2: 30 Participants will be recruited after filling the consent form and screened through a questionnaire throughout the university. Individuals with Body Mass Index[BMI] >23kg/m2, Waist-Hip-Ratio >0.8 will be recruited in the study after fulfilling the criterion (patients of thyroid, Polycystic ovary syndrome[PCOS], Hypertension[HTN] will be excluded). Participants not following any fitness regime or specific diet will be recruited further. Baseline body measurements will be taken by inbody analyzer. They will be given powder packed in packets to be used for 8 weeks twice a day before breakfast and dinner. Experimental Design : Overweight and obese adults will be assigned to two groups ( Intervention group and control). Participants will be requested to record the following information daily: Consumption of FCP( fenugreek cumin powder) and any side effects if experienced after consumption.

The control group will not receive powder or any other intervention. Phase 3: Measurements will be taken after intervention

Statistical Analysis:

Microsoft excel will be used for data coding. Descriptive analysis will be done by using SPSS[Statistical Package for Social Sciences] version 23( SPSS for windows version 23; SPSS Inc., Chicago).

Independent sample t-test and Pearson chi-square will be performed to compare the treatment and control groups. P value < 0.05 will be considered significant for all analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • University of veterinary and animal sciences, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • overweight and obese( BMI>23 kg/m^2)

Exclusion Criteria:

  • pregnant women
  • Thyroid
  • PCOS
  • HTN
  • fitness regime
  • specific diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fenugreek cumin powder
Overweight and Obese adults in this group will receive fenugreek cumin powder daily twice a day before morning and evening meals for 8 weeks
Combination product: Fenugreek Cumin Powder
Fenugreek and Cumin seeds will be procured from the market. They will be cleaned of debris, winnowed, and grinded to fine powder passed through a mesh size of 30 for metal cleaning. 5g of fenugreek powder and 5g of cumin powder will be packed in packets. Participants in the intervention group will be instructed to consume the powder before breakfast and dinner with a glass of water.
No Intervention: Control group
Overweight and obese participants in this group will not receive fenugreek and cumin powder or any intervention for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
weight change in kilograms
Time Frame: change from baseline weight after 2 months
Electronic weighing scale will be used to assess weight change in both groups
change from baseline weight after 2 months
Change in Body fat mass in kilograms and percentages
Time Frame: change from baseline readings after 2 months
body fat mass and percentage will be assessed through inbody analyzer 270
change from baseline readings after 2 months
Change in BMI in kg/m^2
Time Frame: change from baseline reading after 2 months
the BMI will be calculated using weight(kg) and height(m^2)
change from baseline reading after 2 months
Change in Waist- Hip Ratio
Time Frame: change from baseline reading after 2 months
the WHR will be calculated using inbody analyzer 270
change from baseline reading after 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Basal metabolic Rate( BMR)
Time Frame: Change from baseline after 2 months
The BMR will be calculated using Inbody analyzer 270
Change from baseline after 2 months
change in Protein mass of body (grams)
Time Frame: change from baseline reading after 2 months
this protein mass will be assessed through Inbody analyzer 270
change from baseline reading after 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanaullah Iqbal, PhD, University of Veterinary and Animal Sciences Lahore, Punjab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fenugreek and cumin powder

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on Fenugreek Cumin Powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings