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

August 27, 2023 updated by: Shatha Hammad, Assistant Professor, University of Jordan

The Influence of Daily Honey Consumption on Insulin Resistance in Obese Women With Insulin Resistance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
    • Amman, Jordan
      • Amman, Amman, Jordan, Jordan, 11942
        • Recruiting
        • Jordan University Hospital
        • Contact:
        • Principal Investigator:
          • Shatha S Hammad, PhD
      • Amman, Amman, Jordan, Jordan, 11942
        • Not yet recruiting
        • The University of Jordan
        • Principal Investigator:
          • Shatha S Hammad, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: Change from Baseline at 4 months
Participants will provide a 3-day food record. Dietary data will be analyzed for energy, macro- and micro-nutrients composition using the food processor SQL version 10.3.0 program (ESHA Research, Salem, Oregon).
Change from Baseline at 4 months
Dietary intake (A daily treatment consumption)
Time Frame: Every day of the treatment period (4 months)
A daily treatment consumption checklist will be filled by each participant using the mobile App.
Every day of the treatment period (4 months)
Anthropometric measurements (Height)
Time Frame: On the first day
Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.
On the first day
Anthropometric measurements (Weight)
Time Frame: Change from Baseline at 4 months
Weight will be measured using a calibrated digital scale to the nearest 0.1 kg. All participants will be measured in light clothing and without any heavy articles or footwear.
Change from Baseline at 4 months
Anthropometric measurements (Waist circumference)
Time Frame: Change from Baseline at 4 months
The average waist circumference will be calculated from 2 consecutive measurements at the midway between the lowest rib and iliac crest.
Change from Baseline at 4 months
Anthropometric measurements (A body composition assessment)
Time Frame: Change from Baseline at 4 months
A body composition assessment will be performed using InBody120 analyzer (InBody, CO.). Participants will be asked to remove any metal items and heavy clothes before scanning, and will be scanned barefoot and wearing light clothes. Participant positioning will be conducted in accordance with the operator's manual.A trained operator will assess body composition according to the manufacturer's instructions.
Change from Baseline at 4 months
Biochemical measurements (OGTT)
Time Frame: Change from Baseline at 4 months
OGTT (75 g of glucose) will be executed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OGTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.
Change from Baseline at 4 months
Biochemical measurements (OHTT)
Time Frame: Change from Baseline at 4 months
OHTT (75 g of honey) will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws. During OHTT venous blood samples will be obtained at 0, 30, 60, 90 and 120 min for the determination of glucose and insulin.
Change from Baseline at 4 months
Biochemical measurements (Glucose level)
Time Frame: Change from Baseline at 4 months
Glucose level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (Insulin level)
Time Frame: Change from Baseline at 4 months
Insulin level test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (HbA1C)
Time Frame: Change from Baseline at 4 months
HbA1C test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (Adiponectin)
Time Frame: Change from Baseline at 4 months
Adiponectin test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (C-reactive protein)
Time Frame: Change from Baseline at 4 months
C-reactive protein test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (Triglyceride)
Time Frame: Change from Baseline at 4 months
Triglyceride test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (Total cholesterol)
Time Frame: Change from Baseline at 4 months
Total cholesterol test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months
Biochemical measurements (High density lipoprotein- cholesterol (HDL-C))
Time Frame: Change from Baseline at 4 months
High density lipoprotein- cholesterol (HDL-C) test will be performed following an overnight fast and the participants will be instructed to abstain from consuming caffeinated beverages as well as from any type of exercise for 12 hours prior to blood draws.
Change from Baseline at 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake (3-day food record)
Time Frame: At the beginning of the study
Participants will provide a 3-day food record. Dietary data will be analyzed for energy, macro- and micro-nutrients composition using the food processor SQL version 10.3.0 program (ESHA Research, Salem, Oregon).
At the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Collaborators

Abdul Hameed Shoman Foundation

Investigators

  • Principal Investigator: Shatha S Hammad, PhD, The University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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