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

Primary Purpose

Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Honey
Other carbohydrate alternatives such as jell-o
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Insulin resistance

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Jordan University HospitalRecruiting
  • The University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Honey

Other carbohydrate alternatives

Arm 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 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.

Outcomes

Primary Outcome Measures

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).
Dietary intake (A daily treatment consumption)
A daily treatment consumption checklist will be filled by each participant using the mobile App.
Anthropometric measurements (Height)
Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
August 27, 2023
Sponsor
University of Jordan
Collaborators
Abdul Hameed Shoman Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05427799
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
Collaborators
Abdul Hameed Shoman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a parallel, single-blind, randomized trial
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Honey
Arm Type
Experimental
Arm 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.
Arm Title
Other carbohydrate alternatives
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Honey
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Other carbohydrate alternatives such as jell-o
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dietary intake
Description
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).
Time Frame
Change from Baseline at 4 months
Title
Dietary intake (A daily treatment consumption)
Description
A daily treatment consumption checklist will be filled by each participant using the mobile App.
Time Frame
Every day of the treatment period (4 months)
Title
Anthropometric measurements (Height)
Description
Standing height, without footwear, will be taken using stadiometer to the nearest 0.1 cm.
Time Frame
On the first day
Title
Anthropometric measurements (Weight)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Anthropometric measurements (Waist circumference)
Description
The average waist circumference will be calculated from 2 consecutive measurements at the midway between the lowest rib and iliac crest.
Time Frame
Change from Baseline at 4 months
Title
Anthropometric measurements (A body composition assessment)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (OGTT)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (OHTT)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (Glucose level)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (Insulin level)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (HbA1C)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (Adiponectin)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (C-reactive protein)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (Triglyceride)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (Total cholesterol)
Description
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.
Time Frame
Change from Baseline at 4 months
Title
Biochemical measurements (High density lipoprotein- cholesterol (HDL-C))
Description
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.
Time Frame
Change from Baseline at 4 months
Other Pre-specified Outcome Measures:
Title
Dietary intake (3-day food record)
Description
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).
Time Frame
At the beginning of the study

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obese women with insulin resistance
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shatha S Hammad, PhD
Phone
+96265355000
Ext
22427
Email
sh.hammad@ju.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shatha S Hammad, PhD
Organizational Affiliation
The University of Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
State/Province
Amman, Jordan
ZIP/Postal Code
11942
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara M Alhalaiqah
Email
honeyresearch1@gmail.com
First Name & Middle Initial & Last Name & Degree
Shatha S Hammad, PhD
Facility Name
The University of Jordan
City
Amman
State/Province
Amman, Jordan
ZIP/Postal Code
11942
Country
Jordan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shatha S Hammad, PhD
Phone
+96265355000
Ext
22427
Email
sh.hammad@ju.edu.jo
First Name & Middle Initial & Last Name & Degree
Shatha S Hammad, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4989131/
Description
Prevalence and Associated Factors of Insulin Resistance in Adults from Maracaibo City, Venezuela

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

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