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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
United Arab Emirates University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Visceral Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 15, 2017
Last Updated
August 16, 2020
Sponsor
United Arab Emirates University
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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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