Metabolic SyndromeGRAINNCT00924521
Grains Reduce Adiposity and Improve Nutrition Study
A study testing Whole grain diet and Refined grain in people with Metabolic Syndrome and Insulin Resistance, run by Penn State University at 1 site in United States.
Trial summary
Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance
- What is being tested?
- Whole grain diet and Refined grain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2011
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 25 to < 42
- Waist circumference of > 40 inches for males and > 35 inches for females and having one other of the criteria for metabolic syndrome will be recruited
- In this population, we will also accept the following:
- LDL-C < 175 mg/dL
- HDL-C > 25 mg/dL
- Triglycerides < 400 mg/dL
- All subjects will be required to meet one specific criteria for metabolic syndrome beyond increased waist circumference
Who cannot join
- Smokers
- Have insulin-dependent diabetes
- Are pregnant or expecting to be pregnant, lactating in the last 6 months
- Are taking NSAIDS or other medications known to affect inflammatory markers or drugs affecting glucose metabolism
- Blood pressure lowering medications are acceptable if the person has controlled BP at screening, <140/90 mmHg.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Grains Reduce Adiposity and Improve Nutrition Study (GRAINS) Increased Whole Grain Intake - Beneficial Effects on Visceral Adiposity, Vascular Function and Glucose Metabolism/Insulin Resistance
Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Additional research is needed with regard to the mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed study aims to address these issues and in addition, includes exploratory work with adipocytes in cell culture to evaluate the effects of whole grains on adipocyte function.
Hypothesis:
There will be a greater reduction in visceral adiposity, indicators of insulin resistance (HOMA score), improvement in inflammatory status and improvement in adipokine levels after six weeks of a weight stable period and after six weeks of weight loss in subjects consuming 6-9 servings compared to 0 servings of whole grains per day.
Read the detailed description
Including whole grains as part of a heart-healthy diet has been shown to be beneficial in decreasing body weight and body fat. The beneficial effects of whole grains on body weight may be explained by the larger volume and relatively low energy density of whole grain food thus leading to increased satiation. Reducing visceral fat is of particular importance as visceral adiposity has been associated with increased risk for metabolic diseases and cardiovascular disease.
The proposed study is a randomized, 2-parallel arm controlled feeding study. Subjects will be fed one of two weight maintenance diets (refined grain and whole grain) for 6 weeks, followed by a 6 week controlled weight loss period where subjects are fed the same diets, but at a reduced calorie level, designed to elicit weight loss (~2 lbs per week). Diets for both groups will have the same nutrient profile (percent of calories from fat, protein, carbohydrates, etc.); however, the whole grain (WG) group will substitute whole grains for refined grains in their grain intake (breads, tortillas, cereals, etc.). The WG group will be expected to take in 6-9 servings of whole grains per day on both diets. Plasma endpoints will be measured at baseline and at the end of the 6-week diet periods. Blood samples also will be taken at the mid-point of each period and held for analysis if deemed appropriate after initial data is reviewed. Endo-PAT will be conducted at baseline and at the end of each diet period as well as DEXA and MRI testing.
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Being tested
- Whole grain diet, Refined grain
- Keywords
- grains, fiber, metabolic syndrome, insulin
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain dietDietary supplement
Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment.
Refined grainDietary supplement
Participants in this group will receive only refined grains as typically consumed in the average American diet.
| Study group | Role | What they receive |
|---|---|---|
| Refined grain | Active comparator | Participants in this group will receive only refined grains as typically consumed in the average American diet. Receives: Dietary Supplement: Refined grain |
| Whole grain diet | Experimental | Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment. Receives: Dietary Supplement: Whole grain diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
To assess regional changes in body fat deposition, subjects will undergo a dual energy X-ray absorptiometry (DXA) scan at baseline (beginning of study) and end of each intervention period. Waist circumference measurements also will be taken at this time to track how much fat is lost from the abdominal area of the body.
Measured: Week 6 and 12 - End of diet period 1 and 2
Secondary outcomes (6)
Fasting glucose
Twelve-hour fasting blood samples (30ml) will be collected for analyses of plasma glucose levels.
Measured: Time 0, week 6 and week 14 - Baseline end of each diet period
Plasma cytokines
Twelve-hour fasting blood samples (30ml) will be collected for analyses of plasma C-reactive protein and inflammatory cytokines. Blood samples obtained at baseline will be used to measure baseline values for study endpoints, whereas blood samples obtained at the end of each diet period will measure final endpoint values.
Measured: Week 0, week 6 and week 14 - Baseline end of each diet period
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: Week 0, week 6 and week 14 - Baseline end of each diet period
Resting Metabolic Rate
The COSMED Fitmate is a state-of-the-art resting metabolic rate machine that takes accurate, quick readings of your oxygen use. Participants will lie quietly without moving for 30 minutes upon arrival. A mask will be placed around the nose and mouth and participant will be asked to remain still for another 15 min will resting metabolic rate is measured. The test provides valuable information about how much energy (calories) an individual burns in a 24-hour period. The test will take ~15 min to complete.
Measured: Week 0 and week 14 - Baseline and end of diet period 2
Appetite Hormones
Twelve-hour fasting blood samples (30ml) will be collected to assess changes in plasma appetite hormones across the two diet periods.
Measured: Week 0, week 6 and week 14 - Baseline end of each diet period
Abdominal obesity
A subset of subjects will undergo magnetic resonance imaging (MRI) scans in the abdominal region by standard protocols. Subjects will be placed in a prone position in the magnet with their arms stretched above their head. A series of 40-47 T1-weighed axial spin echo images, will be taken in the abdominal region using established body landmarks. Body compartment volumes for total abdominal and visceral adipose tissue, as well as muscle, will then be obtained by tissue integration analysis.
Measured: Week 14 - End of diet period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924521
- Sponsor's protocol ID
- PKE GRAIN
- Acronym
- GRAIN
- Status last verified
- Aug 2023
- First submitted
- 18 Jun 2009
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008 Jan;87(1):79-90. doi: 10.1093/ajcn/87.1.79.
PubMed 18175740Harris Jackson K, West SG, Vanden Heuvel JP, Jonnalagadda SS, Ross AB, Hill AM, Grieger JA, Lemieux SK, Kris-Etherton PM. Effects of whole and refined grains in a weight-loss diet on markers of metabolic syndrome in individuals with increased waist circumference: a randomized controlled-feeding trial. Am J Clin Nutr. 2014 Aug;100(2):577-86. doi: 10.3945/ajcn.113.078048. Epub 2014 Jun 18.
PubMed 24944054
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grains Reduce Adiposity and Improve Nutrition Study (GRAINS) Increased Whole Grain Intake - Beneficial Effects on Visceral Adiposity, Vascular Function and Glucose Metabolism/Insulin Resistance
- ClinicalTrials.gov ID
- NCT00924521
- Acronym / sponsor ID
- GRAIN / PKE GRAIN
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Keywords
- grains, fiber, metabolic syndrome, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Jun 2009 (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.
Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Additional research is needed with regard to the mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed study aims to address these issues and in addition, includes exploratory work with adipocytes in cell culture to evaluate the effects of whole grains on adipocyte function.
Hypothesis:
There will be a greater reduction in visceral adiposity, indicators of insulin resistance (HOMA score), improvement in inflammatory status and improvement in adipokine levels after six weeks of a weight stable period and after six weeks of weight loss in subjects consuming 6-9 servings compared to 0 servings of whole grains per day.
Detailed description
Including whole grains as part of a heart-healthy diet has been shown to be beneficial in decreasing body weight and body fat. The beneficial effects of whole grains on body weight may be explained by the larger volume and relatively low energy density of whole grain food thus leading to increased satiation. Reducing visceral fat is of particular importance as visceral adiposity has been associated with increased risk for metabolic diseases and cardiovascular disease.
The proposed study is a randomized, 2-parallel arm controlled feeding study. Subjects will be fed one of two weight maintenance diets (refined grain and whole grain) for 6 weeks, followed by a 6 week controlled weight loss period where subjects are fed the same diets, but at a reduced calorie level, designed to elicit weight loss (~2 lbs per week). Diets for both groups will have the same nutrient profile (percent of calories from fat, protein, carbohydrates, etc.); however, the whole grain (WG) group will substitute whole grains for refined grains in their grain intake (breads, tortillas, cereals, etc.). The WG group will be expected to take in 6-9 servings of whole grains per day on both diets. Plasma endpoints will be measured at baseline and at the end of the 6-week diet periods. Blood samples also will be taken at the mid-point of each period and held for analysis if deemed appropriate after initial data is reviewed. Endo-PAT will be conducted at baseline and at the end of each diet period as well as DEXA and MRI testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refined grain | Active comparator | Dietary Supplement: Refined grainParticipants in this group will receive only refined grains as typically consumed in the average American diet. |
| Whole grain diet | Experimental | Dietary Supplement: Whole grain dietParticipants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI > 25 to < 42
- Waist circumference of > 40 inches for males and > 35 inches for females and having one other of the criteria for metabolic syndrome will be recruited
- In this population, we will also accept the following:
- All subjects will be required to meet one specific criteria for metabolic syndrome beyond increased waist circumference
Key exclusion criteria (5 listed)
- Smokers
- Have insulin-dependent diabetes
- Are pregnant or expecting to be pregnant, lactating in the last 6 months
- Are taking NSAIDS or other medications known to affect inflammatory markers or drugs affecting glucose metabolism
- Blood pressure lowering medications are acceptable if the person has controlled BP at screening, <140/90 mmHg.
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 grain dietParticipants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment. | Dietary supplement | Whole grain diet |
| Refined grainParticipants in this group will receive only refined grains as typically consumed in the average American diet. | Dietary supplement | Refined grain |
Primary outcome
Body Composition
Time frame: Week 6 and 12 - End of diet period 1 and 2
To assess regional changes in body fat deposition, subjects will undergo a dual energy X-ray absorptiometry (DXA) scan at baseline (beginning of study) and end of each intervention period. Waist circumference measurements also will be taken at this time to track how much fat is lost from the abdominal area of the body.
6 secondary outcomes
Fasting glucose
Time frame: Time 0, week 6 and week 14 - Baseline end of each diet period
Plasma cytokines
Time frame: Week 0, week 6 and week 14 - Baseline end of each diet period
Endothelial Health
Time frame: Week 0, week 6 and week 14 - Baseline end of each diet period
Resting Metabolic Rate
Time frame: Week 0 and week 14 - Baseline and end of diet period 2
Appetite Hormones
Time frame: Week 0, week 6 and week 14 - Baseline end of each diet period
Abdominal obesity
Time frame: Week 14 - End of diet period 2
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 Aug 2023.
- Results publication: PubMed 18175740Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008 Jan;87(1):79-90. doi: 10.1093/ajcn/87.1.79.
- Derived from this study: PubMed 24944054Harris Jackson K, West SG, Vanden Heuvel JP, Jonnalagadda SS, Ross AB, Hill AM, Grieger JA, Lemieux SK, Kris-Etherton PM. Effects of whole and refined grains in a weight-loss diet on markers of metabolic syndrome in individuals with increased waist circumference: a randomized controlled-feeding trial. Am J Clin Nutr. 2014 Aug;100(2):577-86. doi: 10.3945/ajcn.113.078048. Epub 2014 Jun 18.
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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.
Penny M Kris-Etherton, PhD principal investigator
Penn 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 Whole grain diet and Refined grain in people with Metabolic Syndrome and Insulin Resistance, run by Penn 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 7 inclusion and 5 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 Aug 2023. 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?
Body Composition (time frame: Week 6 and 12 - End of diet period 1 and 2). 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 NCT00924521, which also lists 2 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 Aug 2023.