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

NCT ID: NCT03363542

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Visceral Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

diet rich in fruits, vegetables and/or whole-grain fiber
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Fruits and vegetables rich diet

dietary education to increase fruits and vegetable consumption

Group Type ACTIVE_COMPARATOR

fruits, vegetables and/or whole grain high fiber rich diet

Intervention Type DIETARY_SUPPLEMENT

Dietary education to Increase fruits, vegetables and/or high fiber intake

Whole grain fiber rich diet

dietary education to increase whole grain fiber consumption

Group Type ACTIVE_COMPARATOR

fruits, vegetables and/or whole grain high fiber rich diet

Intervention Type DIETARY_SUPPLEMENT

Dietary education to Increase fruits, vegetables and/or high fiber intake

Fruits and vegetables and whole grain fiber rich diet

dietary education to increase fruits and vegetable and whole grain fiber consumption

Group Type ACTIVE_COMPARATOR

fruits, vegetables and/or whole grain high fiber rich diet

Intervention Type DIETARY_SUPPLEMENT

Dietary education to Increase fruits, vegetables and/or high fiber intake

Control group

Routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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fruits, vegetables and/or whole grain high fiber rich diet

Dietary education to Increase fruits, vegetables and/or high fiber intake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Arab Emirates University

OTHER

Sponsor Role lead

Responsible Party

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Salah Gariballa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salah Gariballa, MD

Role: PRINCIPAL_INVESTIGATOR

United Arab Emirates University

Locations

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United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Salah Gariballai, MD

Role: CONTACT

+97137137659

Shaikha Alshamsi, BSc

Role: CONTACT

+97137137421

Facility Contacts

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Mohammaed

Role: primary

037137118

Robers

Role: backup

037137182

Other Identifiers

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AJF201608

Identifier Type: -

Identifier Source: org_study_id

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