Clinical trial NCT05427799: The Influence of Daily Honey Consumption on IR in Obese Women with IR
Official title: The Influence of Daily Honey Consumption on Insulin Resistance in Obese Women with Insulin Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin resistance
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Abdul Hameed Shoman Foundation
First posted: 2022-06-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel, single-blind, randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dietary intake
timeFrame: Change from Baseline at 4 months
measure: Dietary intake (A daily treatment consumption)
timeFrame: Every day of the treatment period (4 months)
measure: Anthropometric measurements (Height)
timeFrame: On the first day
measure: Anthropometric measurements (Weight)
timeFrame: Change from Baseline at 4 months
measure: Anthropometric measurements (Waist circumference)
timeFrame: Change from Baseline at 4 months
measure: Anthropometric measurements (A body composition assessment)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (OGTT)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (OHTT)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (Glucose level)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (Insulin level)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (HbA1C)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (Adiponectin)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (C-reactive protein)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (Triglyceride)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (Total cholesterol)
timeFrame: Change from Baseline at 4 months
measure: Biochemical measurements (High density lipoprotein- cholesterol (HDL-C))
timeFrame: Change from Baseline at 4 months
Secondary outcomes:
Other outcomes:
measure: Dietary intake (3-day food record)
timeFrame: At the beginning of the study
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
state: Amman, Jordan
city: Amman
country: Jordan
facility: The University of Jordan
state: Amman, Jordan
Study officials:
affiliation: The University of Jordan
name: Shatha S Hammad, PhD
role: PRINCIPAL_INVESTIGATOR
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