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

NCT03363542 | Unknown

• 1 other identifier: AJF201608
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Obesity

Outcome Measures

Primary Outcomes (1)

• Waist circumference in cm

  Change in waist circumference

  baseline and 6 months

Study Arms (4)

Fruits and vegetables rich diet

ACTIVE COMPARATOR

dietary education to increase fruits and vegetable consumption

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

Whole grain fiber rich diet

ACTIVE COMPARATOR

dietary education to increase whole grain fiber consumption

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

Fruits and vegetables and whole grain fiber rich diet

ACTIVE COMPARATOR

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

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

Control group

NO INTERVENTION

Routine care

Interventions

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

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

Fruits and vegetables and whole grain fiber rich diet; Fruits and vegetables rich diet; Whole grain fiber rich diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with visceral obesity (WC=\>88 cm for women and =\>92 cm for men).

You may not qualify if:

• 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

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

United Arab Emirates University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Fruit

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Salah Gariballa, MD

  United Arab Emirates University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salah Gariballai, MD

CONTACT

+97137137659; s.gariballa@uaeu.ac.ae

Shaikha Alshamsi, BSc

CONTACT

+97137137421; alshamsi.shaikha@uaeu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: diet rich in fruits, vegetables and/or whole-grain fiber

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: December 6, 2017
• Study Start: October 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)