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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03363542
Other study ID # AJF201608
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date August 1, 2021

Study information

Verified date August 2020
Source United Arab Emirates University
Contact Salah Gariballai, MD
Phone +97137137659
Email s.gariballa@uaeu.ac.ae
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 332
Est. completion date August 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
fruits, vegetables and/or whole grain high fiber rich diet
Dietary education to Increase fruits, vegetables and/or high fiber intake

Locations

Country Name City State
United Arab Emirates United Arab Emirates University Al Ain Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
United Arab Emirates University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waist circumference in cm Change in waist circumference baseline and 6 months
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