NCT05966935

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 14, 2023

Last Update Submit

July 7, 2024

Conditions

Keywords

Fenugreek powderCumin powderBody CompositionAnthropometric Indices

Outcome Measures

Primary Outcomes (4)

  • weight change in kilograms

    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

    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

    the BMI will be calculated using weight(kg) and height(m\^2)

    change from baseline reading after 2 months

  • Change in Waist- Hip Ratio

    the WHR will be calculated using inbody analyzer 270

    change from baseline reading after 2 months

Secondary Outcomes (2)

  • Change in Basal metabolic Rate( BMR)

    Change from baseline after 2 months

  • change in Protein mass of body (grams)

    change from baseline reading after 2 months

Study Arms (2)

fenugreek cumin powder

EXPERIMENTAL

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

Control group

NO INTERVENTION

Overweight and obese participants in this group will not receive fenugreek and cumin powder or any intervention for 8 weeks

Interventions

Fenugreek Cumin PowderCOMBINATION_PRODUCT

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.

fenugreek cumin powder

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary and Animal Sciences, Lahore

Lahore, 54000, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 7649611BACKGROUND
  • 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.

    PMID: 31583253BACKGROUND
  • 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.

    PMID: 32326942BACKGROUND
  • 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.

    PMID: 33424396BACKGROUND
  • 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.

    PMID: 24868532BACKGROUND
  • 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.

    PMID: 33325302BACKGROUND
  • 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.

    PMID: 19353539BACKGROUND
  • 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.

    PMID: 34825421BACKGROUND
  • 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.

    PMID: 30874277BACKGROUND
  • 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.

    PMID: 18952688BACKGROUND
  • 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.

    PMID: 27070043BACKGROUND
  • 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.

    PMID: 24102093BACKGROUND

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sanaullah Iqbal, PhD

    University of Veterinary and Animal Sciences Lahore, Punjab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be divided into two groups. One group will receive the Fenugreek Cumin Powder. The other group will not receive the powder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 1, 2023

Study Start

September 15, 2023

Primary Completion

November 20, 2023

Study Completion

December 28, 2023

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations