Digestive Health and Immune FunctionNCT01902394
The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses
A study testing Whole grains and Refined grains in people with Digestive Health and Immune Function, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health and Immune Function
- What is being tested?
- Whole grains and Refined grains
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2014
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Self reported weight change >4kg within the past 3 months.
- Have participated in a weight loss program within the last 3-months; eligible if in weight reduction program to maintain body weight.
- Not willing to reduce habitual daily fiber intake (including prebiotics) within 2 wk prior to enrollment to < ~7g/1000kcal/d for men, or <~8g/1000kcal/d for women if currently consuming greater amounts.
- Not willing to stop consumption of probiotic or prebiotic supplements within 2 weeks prior to start of study if currently taking these, as well as during study participation.
- Vegetarian diet.
- Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), including fish oil or n-3 fatty acids and herbal supplements, for 30 days prior to or during study participation, if currently taking these.
Show all 34Show fewer
- Regular use of laxatives, stool softeners, or anti-diarrheal medications, and medications influencing food intake and/or appetite.
- Not willing to undergo a 3-month washout period after colonoscopy prior to enrollment, and not willing to defer colonoscopy until after study completion.
- Eating disorder within the past 10 years.
- Disinhibited eating behavior as indicated by a score above 12 on the Three Factor Eating Questionnaire.
- Food allergies or aversions or other issues with foods that would preclude use of study diets, including gluten, milk, nuts, or eggs.
- Individuals identified during screening as having barriers expected to deter compliance with dietary requirements (e.g., stated dislike of study foods, inadequate resources to store and reheat meals, inability to adhere to food pick-up schedule).
- Alcohol consumption >2 drinks per day.
- Not willing to abstain from alcohol consumption during the study.
- Smoking or using nicotine containing products in the last 6 months.
- Use of aspirin, non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or the inability to discontinue the use of these substances for 72 hrs before first day blood draw until 48 hrs after DTH implant (i.e. after second reading).
- Use of anabolic steroids, insulin, growth hormone or testosterone.
- Type I or type II diabetes.
- Uncontrolled major illnesses. (Will include if stable on drugs used to control cardiovascular, liver, and renal diseases, asthma, and dysphagia).
- Current use of proton pump inhibitors and H2 blockers to control acid-reflux/heart burn
- Use of medications which interfere with energy metabolism including oral glycemic agents and insulin.
- Uncontrolled hypertension as determined by study physician or nurse.
- Use of immunosuppressive drugs.
- Active cancer or current cancer diagnosis (except non-melanoma skin cancer).
- Active infection within 2 weeks of study enrollment, blood draws or skin tests; however, may participate if admission is postponed or study activity is rescheduled > 2 weeks after resolution of symptoms.
- Any antibiotic use within the past 3 months, except topical antibiotic use.
- History of dysphagia, malabsorptive disorders, inflammatory bowel disease or other gastrointestinal disorders such as ulcerative colitis, Crohn's disease, celiac disease , chronic diarrhea or constipation.
- Gastric bypass or other surgery for weight loss.
- Splenectomy or partial splenectomy.
- Autoimmune diseases such as rheumatoid arthritis and psoriasis. Autoimmune thyroid disease that has been treated and with stable replacement doses is not an exclusion.
- Taking warfarin or coumadin any time during the previous 6 months.
- Current diagnosis of or treatment for psychosis (i.e. schizophrenia, etc.). Include depression if has been stable on treatment regimen for > 6 months.
- Blindness or deafness not corrected with use of glasses and hearing aids.
- Does not speak English; due to insufficient funds to hire a translator and to get all study materials translated into another language to allow us to recruit non-English speaking participants non-English speakers will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
HNCRA at Tufts University
Boston, Massachusetts, 02111
About this study
The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and composition, and vitamin K status.
The investigators hypothesize that whole grain consumption over a period of 6 weeks will alter the gut microflora toward a more beneficial bacterial profile, improve the immune response while reducing oxidative stress and inflammatory markers, have favorable effects on factors influencing the regulation of body weight and composition,increase bacterial vitamin K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption, vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is hypothesized that, consumption of whole grains will alter statin pharmacokinetics by decreasing rate of statin absorption, resulting in more sustained plasma concentrations.
Read the detailed description
This study is a randomized parallel-arm trial using a six-week dietary intervention following a 2 week run-in period. Healthy volunteers will be randomized to two groups (n=40/group), and consume either a diet rich in whole grains or a diet rich in refined grains provided at estimated energy requirements for 6 weeks. Outcomes will be measured during the run-in period and at week 6 of the intervention. To control for variation in microbiota an additional 10 volunteers will serve as "negative controls" and not undergo any diet intervention.
- Conditions
- Digestive Health and Immune Function
- Being tested
- Whole grains, Refined grains
- Keywords
- digestive health and natural defenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grainsOther
Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.
Refined grainsOther
Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whole grain rich diet | Experimental | Participants in the whole grain (WG) group will receive a diet providing 100% of energy requirements in a diet rich in whole grains. Receives: Other: Whole grains |
| Refined grain rich diet | Placebo comparator | Participants in the refined grain (RG) group will receive a diet providing 100% of energy requirements in a diet rich in refined grains. Receives: Other: Refined grains |
| Negative control | No intervention | Subjects randomized to the negative control group will consume their own usual diet (i.e. not receive foods and beverages from the study). |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in T Cell-mediated immunity
Delayed-type hypersensitivity (DTH) and lymphocyte proliferation will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention to assess adaptive immune function, specifically T cell-mediated immunity.
Measured: week 2 of washout diet and week 6 of diet intervention
change in Lymphocyte proliferation
Whole blood collected at baseline (week 2 of washout period) and at week-6 of the diet intervention will be investigated for the ability of lymphocytes to proliferate by quantifying the incorporation of tritium following mitogen stimulation.
Measured: week 2 of washout diet and week 6 of diet intervention
change in Natural Killer Function
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention
Measured: week 2 of washout diet and week 6 of diet intervention
change in Cytokines
Peripheral blood and stool samples will be analyzed at baseline (week 2 of washout diet) and week-6 of diet intervention for cytokines.
Measured: week 2 of washout diet and week 6 of diet intervention
change in Salivary immunoglobulin A (IgA)
Salivary IgA will be analyzed at baseline (week 2 of washout period) and at week-6 of the diet intervention.
Measured: week 2 of washout diet and week 6 of intervention diet
Secondary outcomes (20)
change in gut microbiota composition
Phylogenetic composition and relative abundance of bacteria in stool will be analyzed from 24-hour fresh sample collected at baseline (week 2 of washout diet) and at week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in cardiovascular health risk factors
Consumption of the whole grain (WG) diet will be beneficial for multiple outcomes of cardiovascular health including a favorable blood lipid profile (low density lipoprotein, very low-density lipoprotein, high density lipoprotein, total cholesterol and triglycerides), and a decrease in blood pressure, and in oxidative stress status (secondary hypothesis).
Measured: week 2 of washout diet and week 6 of intervention diet
change in vitamin K status
Fecal menaquinones concentrations; Fasting serum phylloquinone and menaquinones concentration from 72-hour stool collected at baseline (week 2 of washout diet) and at week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in body composition
Fat and fat free mass; waist and hip circumference
Measured: week 2 of washout diet and week 6 of intervention diet
change in appetite
Visual analog scales to assess hunger, fullness and satisfaction while on the study diet
Measured: Weekly for 8 weeks
change in fasting gut hormone concentration
Plasma glucagon-like peptide-1 and peptide-YY will be measured from blood samples collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in fasting serum leptin
Measured: week 2 of washout diet and week 6 of intervention diet
change in glycemic regulation
48 hr continuous glucose monitoring; fasting serum glucose; fasting serum insulin; HOMA-IR
Measured: week 2 of washout diet and week 6 of intervention diet
change in resting energy metabolism
Resting energy expenditure; substrate oxidation at rest
Measured: week 2 of washout diet and week 6 of intervention diet
change in eating behaviors
Questionnaires will be administered at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in quality of life
Questionnaires will be administered at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in breath hydrogen and methane
Measured: week 2 of washout diet and week 6 of intervention diet
change in stool pH
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in 72hr fecal weight
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in stool water content
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in total stool anaerobic and aerobic bacterial counts
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in stool energy content
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in DNA methylation
Measured: week 2 of washout diet and week 6 of intervention diet
change in concentrations of the cholesterol synthesis (squalene, desmosterol, lathosterol) and absorption (campesterol, sitosterol, cholestanol) markers
Plasma squalene, desmosterol, lathosterol), campesterol, sitosterol, and cholestanol concentrations will be measured at baseline (week 2 of washout diet) and week 6 of intervention diet
Measured: week 2 of washout diet and week 6 of intervention diet
change in serum vitamin D
Measured: week 2 of washout diet and week 6 of intervention diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Digestive Health and Immune FunctionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills, Tufts Medical Center
- Responsible party
- Principal investigator, Simin Meydani, Tufts University
- Investigators
- Simin N Meydani, DVM, PhD, Principal investigator, Human Nutrition Research Center on AgingJunaidah B Barnett, MCH(N), PhD, Study director, Human Nutrition Research Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902394
- Sponsor's protocol ID
- 2720
- Status last verified
- May 2015
- First submitted
- 4 Jun 2012
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karl JP, Meydani M, Barnett JB, Vanegas SM, Barger K, Fu X, Goldin B, Kane A, Rasmussen H, Vangay P, Knights D, Jonnalagadda SS, Saltzman E, Roberts SB, Meydani SN, Booth SL. Fecal concentrations of bacterially derived vitamin K forms are associated with gut microbiota composition but not plasma or fecal cytokine concentrations in healthy adults. Am J Clin Nutr. 2017 Oct;106(4):1052-1061. doi: 10.3945/ajcn.117.155424. Epub 2017 Aug 16.
PubMed 28814395Vanegas SM, Meydani M, Barnett JB, Goldin B, Kane A, Rasmussen H, Brown C, Vangay P, Knights D, Jonnalagadda S, Koecher K, Karl JP, Thomas M, Dolnikowski G, Li L, Saltzman E, Wu D, Meydani SN. Substituting whole grains for refined grains in a 6-wk randomized trial has a modest effect on gut microbiota and immune and inflammatory markers of healthy adults. Am J Clin Nutr. 2017 Mar;105(3):635-650. doi: 10.3945/ajcn.116.146928. Epub 2017 Feb 8.
PubMed 28179226Karl JP, Meydani M, Barnett JB, Vanegas SM, Goldin B, Kane A, Rasmussen H, Saltzman E, Vangay P, Knights D, Chen CO, Das SK, Jonnalagadda SS, Meydani SN, Roberts SB. Substituting whole grains for refined grains in a 6-wk randomized trial favorably affects energy-balance metrics in healthy men and postmenopausal women. Am J Clin Nutr. 2017 Mar;105(3):589-599. doi: 10.3945/ajcn.116.139683. Epub 2017 Feb 8.
PubMed 28179223
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses
- ClinicalTrials.gov ID
- NCT01902394
- Acronym / sponsor ID
- 2720
- Conditions
- Digestive Health and Immune Function
- Keywords
- digestive health and natural defenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- General Mills, Tufts Medical Center
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Jul 2013 (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 this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and composition, and vitamin K status.
The investigators hypothesize that whole grain consumption over a period of 6 weeks will alter the gut microflora toward a more beneficial bacterial profile, improve the immune response while reducing oxidative stress and inflammatory markers, have favorable effects on factors influencing the regulation of body weight and composition,increase bacterial vitamin K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption, vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is hypothesized that, consumption of whole grains will alter statin pharmacokinetics by decreasing rate of statin absorption, resulting in more sustained plasma concentrations.
Detailed description
This study is a randomized parallel-arm trial using a six-week dietary intervention following a 2 week run-in period. Healthy volunteers will be randomized to two groups (n=40/group), and consume either a diet rich in whole grains or a diet rich in refined grains provided at estimated energy requirements for 6 weeks. Outcomes will be measured during the run-in period and at week 6 of the intervention. To control for variation in microbiota an additional 10 volunteers will serve as "negative controls" and not undergo any diet intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole grain rich diet | Experimental | Other: Whole grainsParticipants in the whole grain (WG) group will receive a diet providing 100% of energy requirements in a diet rich in whole grains. |
| Refined grain rich diet | Placebo comparator | Other: Refined grainsParticipants in the refined grain (RG) group will receive a diet providing 100% of energy requirements in a diet rich in refined grains. |
| Negative control | No intervention | –Subjects randomized to the negative control group will consume their own usual diet (i.e. not receive foods and beverages from the study). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (34 listed)
- Self reported weight change >4kg within the past 3 months.
- Have participated in a weight loss program within the last 3-months; eligible if in weight reduction program to maintain body weight.
- Not willing to reduce habitual daily fiber intake (including prebiotics) within 2 wk prior to enrollment to < ~7g/1000kcal/d for men, or <~8g/1000kcal/d for women if currently consuming greater amounts.
- Not willing to stop consumption of probiotic or prebiotic supplements within 2 weeks prior to start of study if currently taking these, as well as during study participation.
- Vegetarian diet.
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 |
|---|---|---|
| Whole grainsFollowing completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks. | Other | Whole grain rich diet |
| Refined grainsFollowing completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks. | Other | Refined grain rich diet |
Primary outcome
change in T Cell-mediated immunity
Time frame: week 2 of washout diet and week 6 of diet intervention
Delayed-type hypersensitivity (DTH) and lymphocyte proliferation will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention to assess adaptive immune function, specifically T cell-mediated immunity.
change in Lymphocyte proliferation
Time frame: week 2 of washout diet and week 6 of diet intervention
Whole blood collected at baseline (week 2 of washout period) and at week-6 of the diet intervention will be investigated for the ability of lymphocytes to proliferate by quantifying the incorporation of tritium following mitogen stimulation.
change in Natural Killer Function
Time frame: week 2 of washout diet and week 6 of diet intervention
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention
change in Cytokines
Time frame: week 2 of washout diet and week 6 of diet intervention
Peripheral blood and stool samples will be analyzed at baseline (week 2 of washout diet) and week-6 of diet intervention for cytokines.
change in Salivary immunoglobulin A (IgA)
Time frame: week 2 of washout diet and week 6 of intervention diet
Salivary IgA will be analyzed at baseline (week 2 of washout period) and at week-6 of the diet intervention.
20 secondary outcomes
change in gut microbiota composition
Time frame: week 2 of washout diet and week 6 of intervention diet
change in cardiovascular health risk factors
Time frame: week 2 of washout diet and week 6 of intervention diet
change in vitamin K status
Time frame: week 2 of washout diet and week 6 of intervention diet
change in body composition
Time frame: week 2 of washout diet and week 6 of intervention diet
change in appetite
Time frame: Weekly for 8 weeks
change in fasting gut hormone concentration
Time frame: week 2 of washout diet and week 6 of intervention diet
change in fasting serum leptin
Time frame: week 2 of washout diet and week 6 of intervention diet
change in glycemic regulation
Time frame: week 2 of washout diet and week 6 of intervention diet
change in resting energy metabolism
Time frame: week 2 of washout diet and week 6 of intervention diet
change in eating behaviors
Time frame: week 2 of washout diet and week 6 of intervention diet
change in quality of life
Time frame: week 2 of washout diet and week 6 of intervention diet
change in breath hydrogen and methane
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool pH
Time frame: week 2 of washout diet and week 6 of intervention diet
change in 72hr fecal weight
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool water content
Time frame: week 2 of washout diet and week 6 of intervention diet
change in total stool anaerobic and aerobic bacterial counts
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool energy content
Time frame: week 2 of washout diet and week 6 of intervention diet
change in DNA methylation
Time frame: week 2 of washout diet and week 6 of intervention diet
change in concentrations of the cholesterol synthesis (squalene, desmosterol, lathosterol) and absorption (campesterol, sitosterol, cholestanol) markers
Time frame: week 2 of washout diet and week 6 of intervention diet
change in serum vitamin D
Time frame: week 2 of washout diet and week 6 of intervention diet
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 21 May 2015.
- Derived from this study: PubMed 28814395Karl JP, Meydani M, Barnett JB, Vanegas SM, Barger K, Fu X, Goldin B, Kane A, Rasmussen H, Vangay P, Knights D, Jonnalagadda SS, Saltzman E, Roberts SB, Meydani SN, Booth SL. Fecal concentrations of bacterially derived vitamin K forms are associated with gut microbiota composition but not plasma or fecal cytokine concentrations in healthy adults. Am J Clin Nutr. 2017 Oct;106(4):1052-1061. doi: 10.3945/ajcn.117.155424. Epub 2017 Aug 16.
- Derived from this study: PubMed 28179226Vanegas SM, Meydani M, Barnett JB, Goldin B, Kane A, Rasmussen H, Brown C, Vangay P, Knights D, Jonnalagadda S, Koecher K, Karl JP, Thomas M, Dolnikowski G, Li L, Saltzman E, Wu D, Meydani SN. Substituting whole grains for refined grains in a 6-wk randomized trial has a modest effect on gut microbiota and immune and inflammatory markers of healthy adults. Am J Clin Nutr. 2017 Mar;105(3):635-650. doi: 10.3945/ajcn.116.146928. Epub 2017 Feb 8.
- Derived from this study: PubMed 28179223Karl JP, Meydani M, Barnett JB, Vanegas SM, Goldin B, Kane A, Rasmussen H, Saltzman E, Vangay P, Knights D, Chen CO, Das SK, Jonnalagadda SS, Meydani SN, Roberts SB. Substituting whole grains for refined grains in a 6-wk randomized trial favorably affects energy-balance metrics in healthy men and postmenopausal women. Am J Clin Nutr. 2017 Mar;105(3):589-599. doi: 10.3945/ajcn.116.139683. Epub 2017 Feb 8.
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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.
Simin N Meydani, DVM, PhD principal investigator
Human Nutrition Research Center on Aging
Junaidah B Barnett, MCH(N), PhD study director
Human Nutrition Research Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grains and Refined grains in people with Digestive Health and Immune Function, 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 0 inclusion and 34 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 21 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. Some participants in this study may receive a placebo. 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?
change in T Cell-mediated immunity (time frame: week 2 of washout diet and week 6 of diet intervention). The study lists 5 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 NCT01902394, which also lists 3 linked publications.
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 21 May 2015.