Metabolic Syndrome XNCT02728570
Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
A study testing High Dietary Flavonoids and Low Dietary Flavonoids in people with Metabolic Syndrome X and Inflammation, run by Utah State University at 1 site in United States.
Trial summary
The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Inflammation
- What is being tested?
- High Dietary Flavonoids and Low Dietary Flavonoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2015
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 35 kg/m2
Who cannot join
- Documented presence of atherosclerotic disease;
- Diabetes mellitus
- Uncontrolled hypertension
- Renal, hepatic, endocrine, gastrointestinal or other systemic disease
- For women, pregnancy, breast feeding or postpartum < 6 months
- History of drug or alcohol abuse
Show all 12Show fewer
- History of depression or mental illness requiring hospitalization within the last 12 months
- Use of antibiotics within the last 6 months
- Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
- Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
- Lifestyle or schedule incompatible with the study protocol
- Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Utah State University, Center for Human Nutrition Studies
Logan, Utah, 84322-9815
About this study
The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.
- Conditions
- Metabolic Syndrome X, Inflammation
- Being tested
- High Dietary Flavonoids, Low Dietary Flavonoids
- Keywords
- flavonoids, insulin resistance, plasma lipids, intestinal microbiome, intestinal inflammation, subclinical inflammation
- Medical subject headings
- Metabolic Syndrome, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dietary FlavonoidsOther
A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing high levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
Low Dietary FlavonoidsOther
A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing low levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
| Study group | Role | What they receive |
|---|---|---|
| Low Flavonoids then High Flavonoids | Experimental | Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. Receives: Other: High Dietary Flavonoids; Other: Low Dietary Flavonoids |
| High Flavonoids then Low Flavonoids | Experimental | Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. Receives: Other: High Dietary Flavonoids; Other: Low Dietary Flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal calprotectin
Primary endpoint for intestinal inflammation
Measured: 6 weeks
Serum C-reactive protein
One of two primary endpoints for systemic inflammation
Measured: 6 weeks
Serum soluble tumor necrosis factor receptor-1
One of two primary endpoints for systemic inflammation
Measured: 6 weeks
Serum insulin
Primary endpoint for insulin resistance
Measured: 6 weeks
Secondary outcomes (13)
Fecal microbiome composition
Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements
Measured: 6 weeks
Fecal short chain fatty acids
Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.
Measured: 6 weeks
Fecal eosinophil protein X
Secondary endpoint for intestinal inflammation
Measured: 6 weeks
Fecal myeloperoxidase
Secondary endpoint for intestinal inflammation
Measured: 6 weeks
Intestinal permeability by four sugar differential absorption test
Secondary endpoint for intestinal inflammation
Measured: 6 weeks
Serum endotoxin
Secondary endpoint for intestinal inflammation
Measured: 6 weeks
Serum interleukin-6
Secondary endpoint for systemic inflammation
Measured: 6 weeks
Serum soluble tumor necrosis factor receptor-2
Secondary endpoint for systemic inflammation
Measured: 6 weeks
Serum fasting glucose
Secondary endpoint for insulin resistance
Measured: 6 weeks
Calculated Homeostatic Model Assessment-Insulin Resistance
Secondary endpoint for insulin resistance
Measured: 6 weeks
Serum C-peptide
Secondary endpoint for insulin resistance
Measured: 6 weeks
Plasma lipids
Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Measured: 6 weeks
Blood pressure
Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lefevre, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728570
- Sponsor's protocol ID
- USU #5483
- Status last verified
- Apr 2016
- First submitted
- 30 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual data will be deposited into a public repository as the data are published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02728570
- Acronym / sponsor ID
- USU #5483
- Conditions
- Metabolic Syndrome X, Inflammation
- Keywords
- flavonoids, insulin resistance, plasma lipids, intestinal microbiome, intestinal inflammation, subclinical inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Apr 2016 (estimated)
- 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 have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Flavonoids then High Flavonoids | Experimental | Other: High Dietary Flavonoids, Other: Low Dietary FlavonoidsParticipants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. |
| High Flavonoids then Low Flavonoids | Experimental | Other: High Dietary Flavonoids, Other: Low Dietary FlavonoidsParticipants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 25 and 35 kg/m2
Key exclusion criteria (12 listed)
- Documented presence of atherosclerotic disease;
- Diabetes mellitus
- Uncontrolled hypertension
- Renal, hepatic, endocrine, gastrointestinal or other systemic disease
- For women, pregnancy, breast feeding or postpartum < 6 months
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 |
|---|---|---|
| High Dietary FlavonoidsA prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing high levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids. | Other | High Flavonoids then Low Flavonoids, Low Flavonoids then High Flavonoids |
| Low Dietary FlavonoidsA prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing low levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids. | Other | High Flavonoids then Low Flavonoids, Low Flavonoids then High Flavonoids |
Primary outcome
Fecal calprotectin
Time frame: 6 weeks
Primary endpoint for intestinal inflammation
Serum C-reactive protein
Time frame: 6 weeks
One of two primary endpoints for systemic inflammation
Serum soluble tumor necrosis factor receptor-1
Time frame: 6 weeks
One of two primary endpoints for systemic inflammation
Serum insulin
Time frame: 6 weeks
Primary endpoint for insulin resistance
13 secondary outcomes
Fecal microbiome composition
Time frame: 6 weeks
Fecal short chain fatty acids
Time frame: 6 weeks
Fecal eosinophil protein X
Time frame: 6 weeks
Fecal myeloperoxidase
Time frame: 6 weeks
Intestinal permeability by four sugar differential absorption test
Time frame: 6 weeks
Serum endotoxin
Time frame: 6 weeks
Serum interleukin-6
Time frame: 6 weeks
Serum soluble tumor necrosis factor receptor-2
Time frame: 6 weeks
Serum fasting glucose
Time frame: 6 weeks
Calculated Homeostatic Model Assessment-Insulin Resistance
Time frame: 6 weeks
Serum C-peptide
Time frame: 6 weeks
Plasma lipids
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: Yes. De-identified individual data will be deposited into a public repository as the data are published.
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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.
Michael Lefevre, PhD principal investigator
Utah State 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 High Dietary Flavonoids and Low Dietary Flavonoids in people with Metabolic Syndrome X and Inflammation, run by Utah State University 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 1 inclusion and 12 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 15 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fecal calprotectin (time frame: 6 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?
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 15 Apr 2016.