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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
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 14, 2023
    Last Updated
    September 19, 2023
    Sponsor
    University of Veterinary and Animal Sciences, Lahore - Pakistan
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    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
    Citations:
    PubMed Identifier
    7649611
    Citation
    Khosla P, Gupta DD, Nagpal RK. Effect of Trigonella foenum graecum (Fenugreek) on blood glucose in normal and diabetic rats. Indian J Physiol Pharmacol. 1995 Apr;39(2):173-4.
    Results Reference
    background
    PubMed Identifier
    31583253
    Citation
    Geberemeskel GA, Debebe YG, Nguse NA. Antidiabetic Effect of Fenugreek Seed Powder Solution (Trigonella foenum-graecum L.) on Hyperlipidemia in Diabetic Patients. J Diabetes Res. 2019 Sep 5;2019:8507453. doi: 10.1155/2019/8507453. eCollection 2019.
    Results Reference
    background
    PubMed Identifier
    32326942
    Citation
    Hameed S, Arshad MS, Ahmad RS, Hussain G, Imran M, Arshad MU, Ahmed A, Imran M, Imran A. Potential preventive and protective perspectives of different spice powders and their mixtures in rat model. Lipids Health Dis. 2020 Apr 23;19(1):78. doi: 10.1186/s12944-020-01223-9.
    Results Reference
    background
    PubMed Identifier
    33424396
    Citation
    Khateeb S, Albalawi A, Alkhedaide A. Regulatory effect of diosgenin on lipogenic genes expression in high-fat diet-induced obesity in mice. Saudi J Biol Sci. 2021 Jan;28(1):1026-1032. doi: 10.1016/j.sjbs.2020.11.045. Epub 2020 Nov 18.
    Results Reference
    background
    PubMed Identifier
    24868532
    Citation
    Kumar P, Bhandari U, Jamadagni S. Fenugreek seed extract inhibit fat accumulation and ameliorates dyslipidemia in high fat diet-induced obese rats. Biomed Res Int. 2014;2014:606021. doi: 10.1155/2014/606021. Epub 2014 Apr 29.
    Results Reference
    background
    PubMed Identifier
    33325302
    Citation
    Laudadio V, Nasiri-Dehbaneh M, Bilal RM, Qotbi A, Javandel F, Ebrahimi A, Seidavi A, Slozhenkina M, Gorlov I, Dunne PG, Tufarelli V. Effects of different levels of dietary black cumin (Nigella sativa L.) and fenugreek (Trigonella foenum-graecum L.) and their combination on productive traits, selected blood constituents, microbiota and immunity of broilers. Anim Biotechnol. 2022 Oct;33(5):941-954. doi: 10.1080/10495398.2020.1853138. Epub 2020 Dec 16.
    Results Reference
    background
    PubMed Identifier
    19353539
    Citation
    Mathern JR, Raatz SK, Thomas W, Slavin JL. Effect of fenugreek fiber on satiety, blood glucose and insulin response and energy intake in obese subjects. Phytother Res. 2009 Nov;23(11):1543-8. doi: 10.1002/ptr.2795.
    Results Reference
    background
    PubMed Identifier
    34825421
    Citation
    Tavakoli-Rouzbehani OM, Faghfouri AH, Anbari M, Nikpayam O, PourMirzaei Olyaei H, Alizadeh M. Efficacy of Cuminum Cyminum supplementation on lipid profile and anthropometric parameters: A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2022 Jan;36(1):380-394. doi: 10.1002/ptr.7327. Epub 2021 Nov 25.
    Results Reference
    background
    PubMed Identifier
    30874277
    Citation
    Peng Y, Sun Q, Xu W, He Y, Jin W, Yuan L, Gao R. Vitexin ameliorates high fat diet-induced obesity in male C57BL/6J mice via the AMPKalpha-mediated pathway. Food Funct. 2019 Apr 1;10(4):1940-1947. doi: 10.1039/c9fo00148d. Epub 2019 Mar 15.
    Results Reference
    background
    PubMed Identifier
    18952688
    Citation
    Said O, Saad B, Fulder S, Khalil K, Kassis E. Weight loss in animals and humans treated with "weighlevel", a combination of four medicinal plants used in traditional arabic and islamic medicine. Evid Based Complement Alternat Med. 2011;2011:874538. doi: 10.1093/ecam/nen067. Epub 2011 Jun 16.
    Results Reference
    background
    PubMed Identifier
    27070043
    Citation
    Sharma MS, Choudhary PR. Effect of Fenugreek Seeds Powder (Trigonella foenum-graecum L.) on Experimental Induced Hyperlipidemia in Rabbits. J Diet Suppl. 2017 Jan 2;14(1):1-8. doi: 10.3109/19390211.2016.1168905. Epub 2016 Apr 12.
    Results Reference
    background
    PubMed Identifier
    24102093
    Citation
    Yadav UC, Baquer NZ. Pharmacological effects of Trigonella foenum-graecum L. in health and disease. Pharm Biol. 2014 Feb;52(2):243-54. doi: 10.3109/13880209.2013.826247. Epub 2013 Oct 9.
    Results Reference
    background

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