Skip to main content
OpenTrials
Completed

NCT Number: NCT05427799

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital, Amman, Amman, Jordan, Jordan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Honey

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 such as jell-o

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.

Primary outcomes

  1. 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).

  2. 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.

  3. Anthropometric measurements (Height)

    Time frame: On the first day

    Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Collaborators

  • Abdul Hameed Shoman Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.