The Influence of Daily Honey Consumption on IR in Obese Women With IR
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Other Outcome Measures
- Dietary intake (3-day food record) [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female
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19-45 years
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Obese (BMI >= 30 kg/m^2)
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Premenopausal
Exclusion Criteria:
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Individual who use any drug or supplements known to affect lipid, glucose for at least the last three months.
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Individual who previous insulin treatment
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Smokers
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Individual who have diabetes, kidney, liver, or hormonal diseases
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Individual who have significant weight changes > 5% during the past 6 months
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Women who are postmenopausal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jordan University Hospital | Amman | Amman, Jordan | Jordan | 11942 |
| 2 | The University of Jordan | Amman | Amman, Jordan | Jordan | 11942 |
Sponsors and Collaborators
- University of Jordan
- Abdul Hameed Shoman Foundation
Investigators
- Principal Investigator: Shatha S Hammad, PhD, The University of Jordan
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 2021/137