The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity

The Effects of Increased Fruits and Vegetables and/or Whole Grain Food Consumption on Cardio Metabolic Risk Factors of Subjects With Visceral Obesity

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.

Study Overview

• Status: Unknown
• Conditions: Visceral Obesity
• Intervention / Treatment: Dietary supplement: fruits, vegetables and/or whole grain high fiber rich diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salah Gariballai, MD; Phone Number: +97137137659; Email: s.gariballa@uaeu.ac.ae
• Study Contact Backup: Name: Shaikha Alshamsi, BSc; Phone Number: +97137137421; Email: alshamsi.shaikha@uaeu.ac.ae

Study Locations

• United Arab Emirates
  • Abu Dhabi
    • Al Ain, Abu Dhabi, United Arab Emirates
      • Recruiting
      • United Arab Emirates University
      • Contact: Mohammaed; Phone Number: 037137118; Email: mmmahmoud@uaeu.ac.ae
      • Contact: Robers; Phone Number: 037137182; Email: dsec.fmhs@uaeu.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine care
Active Comparator: Fruits and vegetables rich diet; dietary education to increase fruits and vegetable consumption	Dietary supplement: fruits, vegetables and/or whole grain high fiber rich diet; Dietary education to Increase fruits, vegetables and/or high fiber intake
Active Comparator: Whole grain fiber rich diet; dietary education to increase whole grain fiber consumption	Dietary supplement: fruits, vegetables and/or whole grain high fiber rich diet; Dietary education to Increase fruits, vegetables and/or high fiber intake
Active Comparator: Fruits and vegetables and whole grain fiber rich diet; dietary education to increase fruits and vegetable and whole grain fiber consumption	Dietary supplement: fruits, vegetables and/or whole grain high fiber rich diet; Dietary education to Increase fruits, vegetables and/or high fiber intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference in cm	Change in waist circumference	baseline and 6 months

Collaborators and Investigators

• Sponsor: United Arab Emirates University
• Investigators: Principal Investigator: Salah Gariballa, MD, United Arab Emirates University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: AJF201608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No