Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363542
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Salah Gariballa, United Arab Emirates University

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.

Condition or disease Intervention/treatment Phase
Visceral Obesity Dietary Supplement: fruits, vegetables and/or whole grain high fiber rich diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: diet rich in fruits, vegetables and/or whole-grain fiber
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
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

No Intervention: Control group
Routine care



Primary Outcome Measures :
  1. Waist circumference in cm [ Time Frame: baseline and 6 months ]
    Change in waist circumference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363542


Contacts
Layout table for location contacts
Contact: Salah Gariballai, MD +97137137659 s.gariballa@uaeu.ac.ae
Contact: Shaikha Alshamsi, BSc +97137137421 alshamsi.shaikha@uaeu.ac.ae

Locations
Layout table for location information
United Arab Emirates
United Arab Emirates University Recruiting
Al Ain, Abu Dhabi, United Arab Emirates
Contact: Mohammaed    037137118    mmmahmoud@uaeu.ac.ae   
Contact: Robers    037137182    dsec.fmhs@uaeu.ac.ae   
Sponsors and Collaborators
United Arab Emirates University
Investigators
Layout table for investigator information
Principal Investigator: Salah Gariballa, MD United Arab Emirates University
Layout table for additonal information
Responsible Party: Salah Gariballa, Professor, United Arab Emirates University
ClinicalTrials.gov Identifier: NCT03363542    
Other Study ID Numbers: AJF201608
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight