The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity
Primary Purpose
Visceral Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
fruits, vegetables and/or whole grain high fiber rich diet
Sponsored by
About this trial
This is an interventional other trial for Visceral Obesity
Eligibility Criteria
Inclusion Criteria:
- Individuals with visceral obesity (WC=>88 cm for women and =>92 cm for men).
Exclusion Criteria:
- Individuals with severe chronic clinical or psychiatric disease, 2) Participating in other intervention trials, have a special diet or taking supplements. Consent All volunteers will be required to provide informed written consent
Sites / Locations
- United Arab Emirates UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Fruits and vegetables rich diet
Whole grain fiber rich diet
Fruits and vegetables and whole grain fiber rich diet
Control group
Arm Description
dietary education to increase fruits and vegetable consumption
dietary education to increase whole grain fiber consumption
dietary education to increase fruits and vegetable and whole grain fiber consumption
Routine care
Outcomes
Primary Outcome Measures
Waist circumference in cm
Change in waist circumference
Secondary Outcome Measures
Full Information
NCT ID
NCT03363542
First Posted
October 15, 2017
Last Updated
August 16, 2020
Sponsor
United Arab Emirates University
1. Study Identification
Unique Protocol Identification Number
NCT03363542
Brief Title
The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity
Official Title
The Effects of Increased Fruits and Vegetables and/or Whole Grain Food Consumption on Cardio Metabolic Risk Factors of Subjects With Visceral Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Arab Emirates University
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 investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity to examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population. The research will also investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change.
Detailed Description
The United Arab Emirates (UAE) has one of the highest prevalence of obesity related diabetes mellitus in the World [3]. Visceral (abdominal) obesity is particularly common and more closely related to morbidity in the UAE. The investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity, the aims of which are: (i) To examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population (ii) To examine the effects of increased fruits, vegetables and/or whole-grain fiber consumption on cardio metabolic risk factors (iii) To investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change. The proposed study will provide the scientific rationale and the methodology for improving the diet and promote healthy eating in the UAE population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
diet rich in fruits, vegetables and/or whole-grain fiber
Masking
Participant
Allocation
Randomized
Enrollment
332 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fruits and vegetables rich diet
Arm Type
Active Comparator
Arm Description
dietary education to increase fruits and vegetable consumption
Arm Title
Whole grain fiber rich diet
Arm Type
Active Comparator
Arm Description
dietary education to increase whole grain fiber consumption
Arm Title
Fruits and vegetables and whole grain fiber rich diet
Arm Type
Active Comparator
Arm Description
dietary education to increase fruits and vegetable and whole grain fiber consumption
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Dietary Supplement
Intervention Name(s)
fruits, vegetables and/or whole grain high fiber rich diet
Intervention Description
Dietary education to Increase fruits, vegetables and/or high fiber intake
Primary Outcome Measure Information:
Title
Waist circumference in cm
Description
Change in waist circumference
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals with visceral obesity (WC=>88 cm for women and =>92 cm for men).
Exclusion Criteria:
Individuals with severe chronic clinical or psychiatric disease, 2) Participating in other intervention trials, have a special diet or taking supplements. Consent All volunteers will be required to provide informed written consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salah Gariballai, MD
Phone
+97137137659
Email
s.gariballa@uaeu.ac.ae
First Name & Middle Initial & Last Name or Official Title & Degree
Shaikha Alshamsi, BSc
Phone
+97137137421
Email
alshamsi.shaikha@uaeu.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Gariballa, MD
Organizational Affiliation
United Arab Emirates University
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Arab Emirates University
City
Al Ain
State/Province
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammaed
Phone
037137118
Email
mmmahmoud@uaeu.ac.ae
First Name & Middle Initial & Last Name & Degree
Robers
Phone
037137182
Email
dsec.fmhs@uaeu.ac.ae
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity
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