The Influence of Daily Honey Consumption on IR in Obese Women With IR

NCT ID: NCT05427799

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-11-30

Brief Summary

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The main objective of the study is to evaluate the effects of daily honey consumption on insulin resistance as a preventive measure against diabetes. in women with insulin resistance.

Detailed Description

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The prevalence rates of insulin resistance (IR) and its health consequences are increasing worldwide. The reputation of honey as a healthy alternative for sugar is largely accepted. Honey contains several bioactive constituents; however, its effect on IR measures and glycemic control is yet to be assessed. We aim to evaluate the effect of daily consumption of honey on IR and inflammatory status measures in obese women with insulin resistance in a free-living controlled intervention study. Sixty obese adult females with insulin resistance will be recruited from the community of the University of Jordan and from patients at the Endocrine unit at the University of Jordan Hospital. Participants will be randomly assigned into one of two treatment groups, honey group or jell-O group. Participants will consume a daily dose of 0.5 mg per kg of body weight of the prescribed treatment for 6 months. The effects of daily consumption of honey on IR, serum concentration of several inflammatory biomarkers, and body fatness will be evaluated. The results of this study would reveal the antidiabetic effect of the bioactive compounds in honey in insulin-resistant obese women.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a parallel, single-blind, randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Honey

Treatment with honey will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption.

During the six months intervention, a daily dose of 0.5 g/kg body weight of honey will be consumed by each participant. Participants will be provided with Mixed flora honey that will be obtained from local producers. The daily dose of treatments will be divided into two doses to simulate a natural pattern of consumption.

All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods.

A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.

Group Type EXPERIMENTAL

Honey

Intervention Type DIETARY_SUPPLEMENT

A mixed flora honey that will be obtained from local producers. and will be consumed by a daily dose of 0.5 g/kg body weight of honey by each participant and will be divided into two doses.

Other carbohydrate alternatives

Treatment with simple sugar alternatives (other carbohydrates, such as jell-o) will extend for four months and the actual treatment phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from honey consumption, and during the study periods.

A daily dose of 0.5 g/kg body weight of jell-O will be consumed by each participant and will be divided into two doses to simulate a natural pattern of consumption. Jell-O was selected as a source of sucrose with negligible phenolic capacity, which will serve as a control.

All participants will be required to limit the consumption of caffeinated beverages to two beverages a day during the study periods.

A nutritionist will calculate the energy requirement and provide dietary instructions and a nutritionally adequate, hypocaloric, balanced sample diet plan with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein will be individualized for each participant monthly.

Group Type PLACEBO_COMPARATOR

Other carbohydrate alternatives such as jell-o

Intervention Type DIETARY_SUPPLEMENT

A daily dose of 0.5 g/kg body weight of Jell-O will be consumed by each participant and will be divided into two doses. Jell-O was selected as a source of sucrose with negligible phenolic capacity.

Interventions

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Honey

A mixed flora honey that will be obtained from local producers. and will be consumed by a daily dose of 0.5 g/kg body weight of honey by each participant and will be divided into two doses.

Intervention Type DIETARY_SUPPLEMENT

Other carbohydrate alternatives such as jell-o

A daily dose of 0.5 g/kg body weight of Jell-O will be consumed by each participant and will be divided into two doses. Jell-O was selected as a source of sucrose with negligible phenolic capacity.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Female
* 19-45 years
* Obese (BMI \>= 30 kg/m\^2)
* Premenopausal

Exclusion Criteria

* Individual who use any drug or supplements known to affect lipid, glucose for at least the last three months.
* Individual who previous insulin treatment
* Smokers
* Individual who have diabetes, kidney, liver, or hormonal diseases
* Individual who have significant weight changes \> 5% during the past 6 months
* Women who are postmenopausal
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abdul Hameed Shoman Foundation

UNKNOWN

Sponsor Role collaborator

University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Shatha Hammad, Assistant Professor

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shatha S Hammad, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Jordan

Locations

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Jordan University Hospital

Amman, Amman, Jordan, Jordan

Site Status

The University of Jordan

Amman, Amman, Jordan, Jordan

Site Status

Countries

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Jordan

References

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Related Links

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Other Identifiers

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2021/137

Identifier Type: -

Identifier Source: org_study_id

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