Metabolic SyndromeNCT02321553
Effect of Brown Rice on the Risk Factors for Metabolic Syndrome
A study testing Brown rice and White rice in people with Metabolic Syndrome, run by Tufts University at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of consumption of brown rice on the risk factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5 weeks each. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Brown rice and White rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men \& postmenopausal women, aged >50 years
- BMI >30 kg/m2 and/or waist/hip ratio >0.9 for men, >0.85 for women
- plus any two of the following four MetS factors
- Fasting plasma TG: 150-400 mg/dL (1.7 - 4.52 mmol/L)
- Fasting plasma HDL cholesterol: <40 mg /dL (1.03 mmol/L) for men, <50 mg/dL (1.29 mmol/L) for women
- Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg
- Fasting plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no medication for blood glucose regulation and no use of insulin
Who cannot join
- Cigarette smoking and/or nicotine replacement use
- Individuals taking estrogen
- Use of blood glucose lowering medications or insulin
- Regular use (>2x/wk) of any stomach acid-lowering medications or laxatives
- Regular use (>2x/wk) of medication for inflammation
- Regular use of medication for hypercoagulation
Show all 21Show fewer
- Cardiovascular (heart) disease
- Gastrointestinal disease
- Renal or chronic kidney disease
- Endocrine disease: including diabetes, untreated thyroid disease
- Rheumatoid arthritis
- Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- Systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg
- Regular use of oral steroids except topical OTC steroids
- Regular daily intake of ≥2 alcoholic drinks
- Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
- Illicit drug use
- Vegetarians
- No fish oil supplements (including cod liver oil) for one month prior to study admission
- No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
- On or planning a weight reducing regimen using a dietary approach of dietary supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translation Research Center, Tufts Medical Center
Boston, Massachusetts, 02111
About this study
Official title: Biological Functions of Brown Rice on Metabolic Syndrome: A Randomized Cross-over Pilot Study
The purpose of the study is to determine the effect of consumption of brown rice on the risk factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5 weeks each. The investigators hypothesize that brown rice will have beneficial effects as it is rich in fiber and also phytochemicals.
Read the detailed description
This is a 2-way cross-over, randomized, placebo controlled, pilot feasibility study to determine the effect of brown rice on the risk factors of metabolic syndrome (MetS). Eligible subjects (n = 9) with the MetS (>50 yr, post-menopausal women and men) will be randomized to receive either brown rice cakes (100 g/d) as treatment or white rice cake as placebo during each 5-wk intervention phase with a 2-wk washout between phases. Subjects will visit Tufts Medical Center for all study visits, at the end of baseline (first 2 week run in phase) and weeks 7, 9 and 14, which will include a 12 hour fasting blood draw. Two sets of three 24 hour dietary recalls will be conducted during the intervention phases. Fasting blood samples will be analyzed for 1) oxidative stress markers (vitamin E concentrations, total antioxidant capacity, and lipid peroxidation product), 2) blood lipid profiles and 3) metabolic risk factors such as plasma glucose, insulin, inflammatory cytokines.
- Conditions
- Metabolic Syndrome
- Being tested
- Brown rice, White rice
- Keywords
- metabolic syndrome, glucose, cholesterol, brown rice, inflammation, oxidative stress
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brown riceOther
brown rice cake
White riceOther
white rice cake
| Study group | Role | What they receive |
|---|---|---|
| Brown Rice | Experimental | Eat 100g of brown rice cake (3 packets) per day for 5 weeks Receives: Other: Brown rice |
| White Rice | Experimental | Eat 100g of white rice cake (3 packets) per day for 5 weeks Receives: Other: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucoregulation (glucose, insulin and HbA1c)
Measured: Change from baseline after 5 week intervention phase
Secondary outcomes (3)
Inflammatory markers (high sensitivity CRP, soluble intercellular adhesion molecule 1, serum amyloid A, vascular cell adhesion molecule 1)
Measured: Change from baseline after 5 week intervention phase
Lipid profile (Total cholesterol, HDL and Triglycerides)
Measured: Change from baseline after 5 week intervention phase
Oxidative stress markers - total antioxidant potential (TAP), total thiols, tocols, Ferric Reducing Antioxidant Power (FRAP), malondialdehyde (MDA), uric acid
Measured: Change from baseline after 5 week intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Chen, Tufts University
- Investigators
- Oliver Chen, Ph.D., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321553
- Sponsor's protocol ID
- 11066
- Status last verified
- May 2015
- First submitted
- 10 Dec 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Functions of Brown Rice on Metabolic Syndrome: A Randomized Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT02321553
- Acronym / sponsor ID
- 11066
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, glucose, cholesterol, brown rice, inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Dec 2014 (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 purpose of the study is to determine the effect of consumption of brown rice on the risk factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5 weeks each. The investigators hypothesize that brown rice will have beneficial effects as it is rich in fiber and also phytochemicals.
Detailed description
This is a 2-way cross-over, randomized, placebo controlled, pilot feasibility study to determine the effect of brown rice on the risk factors of metabolic syndrome (MetS). Eligible subjects (n = 9) with the MetS (>50 yr, post-menopausal women and men) will be randomized to receive either brown rice cakes (100 g/d) as treatment or white rice cake as placebo during each 5-wk intervention phase with a 2-wk washout between phases. Subjects will visit Tufts Medical Center for all study visits, at the end of baseline (first 2 week run in phase) and weeks 7, 9 and 14, which will include a 12 hour fasting blood draw. Two sets of three 24 hour dietary recalls will be conducted during the intervention phases. Fasting blood samples will be analyzed for 1) oxidative stress markers (vitamin E concentrations, total antioxidant capacity, and lipid peroxidation product), 2) blood lipid profiles and 3) metabolic risk factors such as plasma glucose, insulin, inflammatory cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brown Rice | Experimental | Other: Brown riceEat 100g of brown rice cake (3 packets) per day for 5 weeks |
| White Rice | Experimental | Other: White riceEat 100g of white rice cake (3 packets) per day for 5 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men \& postmenopausal women, aged >50 years
- BMI >30 kg/m2 and/or waist/hip ratio >0.9 for men, >0.85 for women
- plus any two of the following four MetS factors
- Fasting plasma TG: 150-400 mg/dL (1.7 - 4.52 mmol/L)
- Fasting plasma HDL cholesterol: <40 mg /dL (1.03 mmol/L) for men, <50 mg/dL (1.29 mmol/L) for women
Key exclusion criteria (21 listed)
- Cigarette smoking and/or nicotine replacement use
- Individuals taking estrogen
- Use of blood glucose lowering medications or insulin
- Regular use (>2x/wk) of any stomach acid-lowering medications or laxatives
- Regular use (>2x/wk) of medication for inflammation
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 |
|---|---|---|
| Brown ricebrown rice cake | Other | Brown Rice |
| White ricewhite rice cake | Other | White Rice |
Primary outcome
Glucoregulation (glucose, insulin and HbA1c)
Time frame: Change from baseline after 5 week intervention phase
3 secondary outcomes
Inflammatory markers (high sensitivity CRP, soluble intercellular adhesion molecule 1, serum amyloid A, vascular cell adhesion molecule 1)
Time frame: Change from baseline after 5 week intervention phase
Lipid profile (Total cholesterol, HDL and Triglycerides)
Time frame: Change from baseline after 5 week intervention phase
Oxidative stress markers - total antioxidant potential (TAP), total thiols, tocols, Ferric Reducing Antioxidant Power (FRAP), malondialdehyde (MDA), uric acid
Time frame: Change from baseline after 5 week intervention phase
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 14 May 2015.
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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.
Oliver Chen, Ph.D. principal investigator
Tufts 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 Brown rice and White rice in people with Metabolic Syndrome, run by Tufts 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 7 inclusion and 21 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 14 May 2015. 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?
Glucoregulation (glucose, insulin and HbA1c) (time frame: Change from baseline after 5 week intervention phase). 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 14 May 2015.