Insulin Resistance
Conditions
Keywords
Insulin resistance
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHoney
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.
DIETARY_SUPPLEMENTOther 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.
Sponsors
University of Jordan
Abdul Hameed Shoman Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
a parallel, single-blind, randomized trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | 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). |
| Dietary intake (A daily treatment consumption) | Every day of the treatment period (4 months) | A daily treatment consumption checklist will be filled by each participant using the mobile App. |
| Anthropometric measurements (Height) | On the first day | Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm. |
| Anthropometric measurements (Weight) | 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. |
| Anthropometric measurements (Waist circumference) | 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. |
| Anthropometric measurements (A body composition assessment) | 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. |
| Biochemical measurements (OGTT) | 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. |
| Biochemical measurements (OHTT) | 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. |
| Biochemical measurements (Glucose level) | 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. |
| Biochemical measurements (Insulin level) | 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. |
| Biochemical measurements (HbA1C) | 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. |
| Biochemical measurements (Adiponectin) | 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. |
| Biochemical measurements (C-reactive protein) | 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. |
| Biochemical measurements (Triglyceride) | 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. |
| Biochemical measurements (Total cholesterol) | 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. |
| Biochemical measurements (High density lipoprotein- cholesterol (HDL-C)) | 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. |
Countries
Jordan
Contacts
PRINCIPAL_INVESTIGATORShatha S Hammad, PhD
The University of Jordan
Outcome results
None listed