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

University of Jordan

Status: Completed

Conditions: Insulin Resistance

Treatments: Dietary Supplement: Other carbohydrate alternatives such as jell-o; Dietary Supplement: Honey

Study type: Interventional

Funder types: Other

Identifiers

NCT05427799

2021/137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Honey

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Honey

Other carbohydrate alternatives

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Other carbohydrate alternatives such as jell-o