Effect of Fenugreek and Cumin Powder on Overweight and Obese People
Primary Purpose
Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fenugreek Cumin Powder
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Fenugreek powder, Cumin powder, Body Composition, Anthropometric Indices
Eligibility Criteria
Inclusion Criteria: overweight and obese( BMI>23 kg/m^2) Exclusion Criteria: pregnant women Thyroid PCOS HTN fitness regime specific diet
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
fenugreek cumin powder
Control group
Arm Description
Overweight and Obese adults in this group will receive fenugreek cumin powder daily twice a day before morning and evening meals for 8 weeks
Overweight and obese participants in this group will not receive fenugreek and cumin powder or any intervention for 8 weeks
Outcomes
Primary Outcome Measures
weight change in kilograms
Electronic weighing scale will be used to assess weight change in both groups
Change in Body fat mass in kilograms and percentages
body fat mass and percentage will be assessed through inbody analyzer 270
Change in BMI in kg/m^2
the BMI will be calculated using weight(kg) and height(m^2)
Change in Waist- Hip Ratio
the WHR will be calculated using inbody analyzer 270
Secondary Outcome Measures
Change in Basal metabolic Rate( BMR)
The BMR will be calculated using Inbody analyzer 270
change in Protein mass of body (grams)
this protein mass will be assessed through Inbody analyzer 270
Full Information
NCT ID
NCT05966935
First Posted
July 14, 2023
Last Updated
September 19, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT05966935
Brief Title
Effect of Fenugreek and Cumin Powder on Overweight and Obese People
Official Title
Effect of Fenugreek and Cumin Powder on Anthropometric Indices of Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Fenugreek powder, Cumin powder, Body Composition, Anthropometric Indices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be divided into two groups. One group will receive the Fenugreek Cumin Powder. The other group will not receive the powder
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fenugreek cumin powder
Arm Type
Experimental
Arm Description
Overweight and Obese adults in this group will receive fenugreek cumin powder daily twice a day before morning and evening meals for 8 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Overweight and obese participants in this group will not receive fenugreek and cumin powder or any intervention for 8 weeks
Intervention Type
Combination Product
Intervention Name(s)
Fenugreek Cumin Powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight change in kilograms
Description
Electronic weighing scale will be used to assess weight change in both groups
Time Frame
change from baseline weight after 2 months
Title
Change in Body fat mass in kilograms and percentages
Description
body fat mass and percentage will be assessed through inbody analyzer 270
Time Frame
change from baseline readings after 2 months
Title
Change in BMI in kg/m^2
Description
the BMI will be calculated using weight(kg) and height(m^2)
Time Frame
change from baseline reading after 2 months
Title
Change in Waist- Hip Ratio
Description
the WHR will be calculated using inbody analyzer 270
Time Frame
change from baseline reading after 2 months
Secondary Outcome Measure Information:
Title
Change in Basal metabolic Rate( BMR)
Description
The BMR will be calculated using Inbody analyzer 270
Time Frame
Change from baseline after 2 months
Title
change in Protein mass of body (grams)
Description
this protein mass will be assessed through Inbody analyzer 270
Time Frame
change from baseline reading after 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
overweight and obese( BMI>23 kg/m^2)
Exclusion Criteria:
pregnant women
Thyroid
PCOS
HTN
fitness regime
specific diet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Rasool, MPhil
Phone
+92336414183
Email
mariarasool1912@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sanaullah Iqbal, PhD
Phone
+923338981489
Email
sanaullah.iqbal@uvas.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanaullah Iqbal, PhD
Organizational Affiliation
University of Veterinary and Animal Sciences Lahore, Punjab
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Fenugreek and Cumin Powder on Overweight and Obese People
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