NCT06119555

Brief Summary

Obesity is a global health concern that significantly affects individuals, and its prevalence is still rising at an alarming rate. While various treatments are available, they often come with unwanted side effects. As a result, there is a growing interest in natural remedies including various herbs and spices such as cinnamon that have a favorable impact on overall health and disease conditions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

November 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

October 31, 2023

Last Update Submit

December 6, 2023

Conditions

Body Composition

Keywords

ObesityCinnamonBody Mass IndexBody Fat MassPercent Body FatSkeletal Muscle MassWaist-to-hip Ratio

Outcome Measures

Primary Outcomes (6)

  • Waist-to-hip ratio

    The waist-to-hip ratio will be assessment before and after intervention with cinnamon powder capsules for 60 days.

    60 days

  • Body weight

    Body weight (Kg) will be assessed before and after intervention with cinnamon powder capsules for 60 days.

    60 days

  • Skeletal muscle mass (SMM)

    Skeletal muscle mass (Kg) will be assessed before and after intervention with cinnamon powder capsules for 60 days.

    60 days

  • Body fat mass

    Body fat mass (Kg) will be assessed before and after intervention with cinnamon powder capsules for 60 days.

    60 days

  • Body mass index (BMI)

    Body mass index (Kg/m\^2) will be assessed before and after intervention with cinnamon powder capsules for 60 days.

    60 days

  • Percent body fat (PBF)

    Percent body fat (%) will be assessed before and after intervention with cinnamon powder capsules for 60 days.

    60 days

Study Arms (2)

Cinnamon Group

EXPERIMENTAL

In the cinnamon group, participants will consume four cinnamon capsules daily for 60 days (each 1.5 grams, totaling 3 grams), two with breakfast and two with dinner.

Dietary Supplement: Cinnamon Capsules

Control Group

NO INTERVENTION

The control group will not receive intervention.

Interventions

Cinnamon CapsulesDIETARY_SUPPLEMENT

The intervention consists of four cinnamon capsules (each 1.5 grams, totaling 3 grams) a day, with two with breakfast and two with dinner for 60 days

Also known as: Cinnamomum, Dalchini, Darchini
Cinnamon Group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese individuals (≥ 25 kg/m\^2)
  • University students of all disciplines
  • Participants of 18-28 years
  • Both male and female

You may not qualify if:

  • Morbid obesity (BMI ≥30 kg/m\^2)
  • Disease conditions (such as cardiovascular diseases, diabetes, hypertension, renal disease, hypothyroidism, and hyperthyroidism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary and Animal Sciences, Lahore - Pakistan

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • Gupta Jain S, Puri S, Misra A, Gulati S, Mani K. Effect of oral cinnamon intervention on metabolic profile and body composition of Asian Indians with metabolic syndrome: a randomized double -blind control trial. Lipids Health Dis. 2017 Jun 12;16(1):113. doi: 10.1186/s12944-017-0504-8.

    PMID: 28606084RESULT

Related Links

MeSH Terms

Conditions

Obesity

Interventions

camphorin protein, Cinnamomum camphora

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ayesha Tariq Sindhu, BSc (Hons) Nutrition

CONTACT

03225884647ayeshatariqsindhu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Food Sciences and Human Nutrition

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

November 25, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

All available data will be confidential

Locations

PA(1)