ObesityNCT02602496
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
A study testing Fruits and Vegetables and Whole Grain in people with Obesity and Overweight, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Fruits and Vegetables and Whole Grain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
- Free of known gastrointestinal disease
- No supplements use (excluding multivitamin)
- Participate in less than 1 h of exercise per week
- Have not taken antibiotics in the last six months
Who cannot join
- Men and women with fruits and vegetable intake exceeding 2 servings/day
- Men and women with whole grain intakes exceeding 1 serving/day
- Pregnant
- Do not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
Read the detailed description
Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.
- Conditions
- Obesity, Overweight
- Being tested
- Fruits and Vegetables, Whole Grain, Control
- Keywords
- Diet, Whole grain, Fruits, Vegetables, Gut health, Anti-inflammatory
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruits and VegetablesOther
5 servings of fruits or vegetables
Whole GrainOther
3 servings of whole grain
ControlOther
3 servings of refined grain
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 3 servings of refined grains per day. Receives: Other: Control |
| Fruits and Vegetables | Experimental | 5 servings of fruits and vegetable per day. Receives: Other: Fruits and Vegetables |
| Whole Grain | Experimental | 3 servings of whole grains per day. Receives: Other: Whole Grain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Measured: 8 weeks
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Measured: 8 weeks
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Measured: 8 weeks
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Measured: 8 weeks
Secondary outcomes (3)
Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)
The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.
Measured: 8 weeks
Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism.
Measured: 8 weeks
Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devin Rose, University of Nebraska Lincoln
- Investigators
- Devin J Rose, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602496
- Sponsor's protocol ID
- UNebraskaLincolnFDST1
- Status last verified
- May 2019
- First submitted
- 4 Nov 2015
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kopf JC, Suhr MJ, Clarke J, Eyun SI, Riethoven JM, Ramer-Tait AE, Rose DJ. Role of whole grains versus fruits and vegetables in reducing subclinical inflammation and promoting gastrointestinal health in individuals affected by overweight and obesity: a randomized controlled trial. Nutr J. 2018 Jul 30;17(1):72. doi: 10.1186/s12937-018-0381-7.
PubMed 30060746
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
- ClinicalTrials.gov ID
- NCT02602496
- Acronym / sponsor ID
- UNebraskaLincolnFDST1
- Conditions
- Obesity, Overweight
- Keywords
- Diet, Whole grain, Fruits, Vegetables, Gut health, Anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
Detailed description
Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Control3 servings of refined grains per day. |
| Fruits and Vegetables | Experimental | Other: Fruits and Vegetables5 servings of fruits and vegetable per day. |
| Whole Grain | Experimental | Other: Whole Grain3 servings of whole grains per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
- Free of known gastrointestinal disease
- No supplements use (excluding multivitamin)
- Participate in less than 1 h of exercise per week
- Have not taken antibiotics in the last six months
Key exclusion criteria (4 listed)
- Men and women with fruits and vegetable intake exceeding 2 servings/day
- Men and women with whole grain intakes exceeding 1 serving/day
- Pregnant
- Do not fit the inclusion criteria
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 and Vegetables5 servings of fruits or vegetables | Other | Fruits and Vegetables |
| Whole Grain3 servings of whole grain | Other | Whole Grain |
| Control3 servings of refined grain | Other | Control |
Primary outcome
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
3 secondary outcomes
Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30060746Kopf JC, Suhr MJ, Clarke J, Eyun SI, Riethoven JM, Ramer-Tait AE, Rose DJ. Role of whole grains versus fruits and vegetables in reducing subclinical inflammation and promoting gastrointestinal health in individuals affected by overweight and obesity: a randomized controlled trial. Nutr J. 2018 Jul 30;17(1):72. doi: 10.1186/s12937-018-0381-7.
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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.
Devin J Rose, PhD principal investigator
University of Nebraska
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 and Vegetables and Whole Grain in people with Obesity and Overweight, run by University of Nebraska Lincoln at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2019. 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 States. 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?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602496, which also lists 1 linked publication.
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 5 Jun 2019.