Visceral ObesityNCT03363542
The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity
A study testing fruits, vegetables and/or whole grain high fiber rich diet in people with Visceral Obesity, run by United Arab Emirates University at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral Obesity
- What is being tested?
- fruits, vegetables and/or whole grain high fiber rich diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Oct 2017to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with visceral obesity (WC=>88 cm for women and =>92 cm for men).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
United Arab Emirates University
Al Ain City, Abu Dhabi Emirate
Mohammaed, 037137118, mmmahmoud@uaeu.ac.ae
Robers, 037137182, dsec.fmhs@uaeu.ac.ae
About this study
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
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.
Read the 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.
- Conditions
- Visceral Obesity
- Being tested
- fruits, vegetables and/or whole grain high fiber rich diet
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruits, vegetables and/or whole grain high fiber rich dietDietary supplement
Dietary education to Increase fruits, vegetables and/or high fiber intake
| Study group | Role | What they receive |
|---|---|---|
| Fruits and vegetables rich diet | Active comparator | dietary education to increase fruits and vegetable consumption Receives: 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 Receives: 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 Receives: Dietary Supplement: fruits, vegetables and/or whole grain high fiber rich diet |
| Control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference in cm
Change in waist circumference
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- diet rich in fruits, vegetables and/or whole-grain fiber
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Gariballa, United Arab Emirates University
- Investigators
- Salah Gariballa, MD, Principal investigator, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363542
- Sponsor's protocol ID
- AJF201608
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03363542
- Acronym / sponsor ID
- AJF201608
- Conditions
- Visceral Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- diet rich in fruits, vegetables and/or whole-grain fiber
| Arm | Type | Receives |
|---|---|---|
| Fruits and vegetables rich diet | Active comparator | Dietary Supplement: fruits, vegetables and/or whole grain high fiber rich dietdietary education to increase fruits and vegetable consumption |
| Whole grain fiber rich diet | Active comparator | Dietary Supplement: fruits, vegetables and/or whole grain high fiber rich dietdietary education to increase whole grain fiber consumption |
| Fruits and vegetables and whole grain fiber rich diet | Active comparator | Dietary Supplement: fruits, vegetables and/or whole grain high fiber rich dietdietary education to increase fruits and vegetable and whole grain fiber consumption |
| Control group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with visceral obesity (WC=>88 cm for women and =>92 cm for men).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruits, vegetables and/or whole grain high fiber rich dietDietary education to Increase fruits, vegetables and/or high fiber intake | Dietary supplement | Fruits and vegetables and whole grain fiber rich diet, Fruits and vegetables rich diet, Whole grain fiber rich diet |
Primary outcome
Waist circumference in cm
Time frame: baseline and 6 months
Change in waist circumference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Gariballa, MD principal investigator
United Arab Emirates University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fruits, vegetables and/or whole grain high fiber rich diet in people with Visceral Obesity, run by United Arab Emirates University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salah Gariballai, MD (+97137137659, s.gariballa@uaeu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference in cm (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.