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

Study Overview
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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.

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Honey
* Dietary Supplement: Other carbohydrate alternatives such as jell-o


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a parallel, single-blind, randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey<br>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<br>* 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.<br>|
| Placebo Comparator: Other carbohydrate alternatives<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake | 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) | 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) | Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm. | On the first day | 
| Anthropometric measurements (Weight) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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)) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin resistance