Insulin ResistanceNCT02186353
Processing Responses of Grains (PRO-Grains) Study
A study testing Partial feeding study in people with Insulin Resistance and Cardiovascular Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The primary objective of this pilot study will be to examine the effects of consuming whole grains, differing in the degree of processing, on insulin sensitivity and other cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets and to generate preliminary data. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Cardiovascular Disease, Diabetes
- What is being tested?
- Partial feeding study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 35 years
- Body mass index ≥ 25 and <40 kg/m2
- Serum fasting insulin >10 uIU/mL and one of the following metabolic syndrome components: waist circumference, men: ≥102 cm, women: ≥88 cm; triglycerides, ≥150 mg/dL; HDL-C, men: <40 mg/dL , women: <50 mg/dL; systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg; or fasting glucose, ≥100 mg/dL
- Medical clearance from a primary care provider to rule out any major medical illness, disability, or disorder (e.g., liver disease, renal failure, cancer)
- Access to a working telephone or cell phone
- Willingness to eat the grain foods provided during participation
- If female, regular menstrual cycles (defined as 26-30 days, ±1 day full flow, i.e. 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)
Who cannot join
- Pre-existing major medical illness by medical history or laboratory screening tests
- Allergy or sensitivity to gluten (self-reported or physician diagnosed)
- >5% change in weight within previous 6 months
- Current smoking (1 cigarette in the past week)
- Major surgery within the previous 6 months
- Physical, mental, or cognitive handicaps that prevent participation.
Show all 13Show fewer
- Alcohol intake >7 drinks per week
- Use of medications that may affect study outcomes
- Use of antibiotics within the previous 3 months (in those who agree to complete the analyses of gut microbiome and fecal short chain fatty acids)
- Use of illegal drugs
- Plans to be away from home for 1 week or longer during the study period (e.g., vacation, relocation)
- Another member of the family (first degree relative) or household participating in the study
- If female, pregnancy or lactation during prior 12 months, plans to become pregnant during the study period, change in oral contraceptives within 3 months, or irregular menstrual cycle frequency (<10 bleeds/year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Effect of Intact vs. Highly Processed Whole Grains on Insulin Sensitivity and Other Cardiometabolic Risk Factors in Hyperinsulinemic Adults
The primary objective of this pilot study will be to examine the effects of consuming whole grains, differing in the degree of processing, on insulin sensitivity and other cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets and to generate preliminary data.
Read the detailed description
In this pilot study, the investigators will access feasibility and generate preliminary data to systematically address a major question in nutrition: Does food processing, specifically with regard to whole grains (WGs), have an independent effect on outcomes related to diabetes and cardiovascular disease? Whole grains are defined as intact, ground, cracked, or flaked caryopsis (kernel or seed), where the principal components (bran, endosperm, germ) are present in the same proportion as the intact caryopsis. In contrast, refined grains (RGs) are milled to remove the bran and germ, leaving only the endosperm and resulting in lower fiber, iron, and many B vitamins. Several previous studies have shown that consumption of WGs vs. RGs improves insulin sensitivity and decreases risk for chronic disease. However, the effects of consuming WGs may differ depending on degree of processing. While whole grain products contain the three components of the kernel, we hypothesize that consuming the food containing the least processed (and least pulverized) kernels may have beneficial effects on metabolism that decrease disease risk through plausible physiological mechanisms.
The investigators propose a partial feeding study using a randomized 3-period crossover design to compare the effects of 1) intact or minimally processed whole grains, 2) highly processed whole grains, and 3) refined grains, each fed for 4 weeks. The primary outcome will be change in peripheral insulin sensitivity. Secondary outcomes include hepatic insulin sensitivity, components of the metabolic syndrome and other cardiometabolic risk factors, arterial stiffness, gut microbiome and fecal short chain fatty acids, and ratings of hunger, satiation, palatability, and acceptability (gastrointestinal symptoms).
- Conditions
- Insulin Resistance, Cardiovascular Disease, Diabetes
- Being tested
- Partial feeding study
- Keywords
- Whole grains, Food processing, Cardiometabolic risk factors
- Medical subject headings
- Insulin Resistance, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial feeding studyBehavioural
Provision of all grain foods where only the processing of kernels used to produce the grain foods will differ among test diets. Each participant will be assigned to complete the three 4-week test diets in random sequence.
| Study group | Role | What they receive |
|---|---|---|
| Intact/minimally processed whole grains | Experimental | Partial feeding study Receives: Behavioral: Partial feeding study |
| Highly processed whole grains | Experimental | Partial feeding study Receives: Behavioral: Partial feeding study |
| Refined grains | Active comparator | Partial feeding study Receives: Behavioral: Partial feeding study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Secondary outcomes (51)
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in body weight at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in body weight at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in body weight at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in dietary intake at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in dietary intake at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in dietary intake at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in physical activity (assessed by accelerometry) at week 4
Measured: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in physical activity (assessed by accelerometry) at week 8
Measured: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in physical activity (assessed by accelerometry) at week 12
Measured: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: Lack of adequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas State University
- Responsible party
- Principal investigator, Julia Wong, Boston Children's Hospital
- Investigators
- Julia MW Wong, PhD, RD, Principal investigator, Boston Children's HospitalDavid S Ludwig, MD, PhD, Study chair, Boston Children's HospitalCara B Ebbeling, PhD, Study chair, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186353
- Sponsor's protocol ID
- P00009343
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intact vs. Highly Processed Whole Grains on Insulin Sensitivity and Other Cardiometabolic Risk Factors in Hyperinsulinemic Adults
- ClinicalTrials.gov ID
- NCT02186353
- Acronym / sponsor ID
- P00009343
- Conditions
- Insulin Resistance, Cardiovascular Disease, Diabetes
- Keywords
- Whole grains, Food processing, Cardiometabolic risk factors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of adequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Kansas State University
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 10 Jul 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 primary objective of this pilot study will be to examine the effects of consuming whole grains, differing in the degree of processing, on insulin sensitivity and other cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets and to generate preliminary data.
Detailed description
In this pilot study, the investigators will access feasibility and generate preliminary data to systematically address a major question in nutrition: Does food processing, specifically with regard to whole grains (WGs), have an independent effect on outcomes related to diabetes and cardiovascular disease? Whole grains are defined as intact, ground, cracked, or flaked caryopsis (kernel or seed), where the principal components (bran, endosperm, germ) are present in the same proportion as the intact caryopsis. In contrast, refined grains (RGs) are milled to remove the bran and germ, leaving only the endosperm and resulting in lower fiber, iron, and many B vitamins. Several previous studies have shown that consumption of WGs vs. RGs improves insulin sensitivity and decreases risk for chronic disease. However, the effects of consuming WGs may differ depending on degree of processing. While whole grain products contain the three components of the kernel, we hypothesize that consuming the food containing the least processed (and least pulverized) kernels may have beneficial effects on metabolism that decrease disease risk through plausible physiological mechanisms.
The investigators propose a partial feeding study using a randomized 3-period crossover design to compare the effects of 1) intact or minimally processed whole grains, 2) highly processed whole grains, and 3) refined grains, each fed for 4 weeks. The primary outcome will be change in peripheral insulin sensitivity. Secondary outcomes include hepatic insulin sensitivity, components of the metabolic syndrome and other cardiometabolic risk factors, arterial stiffness, gut microbiome and fecal short chain fatty acids, and ratings of hunger, satiation, palatability, and acceptability (gastrointestinal symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intact/minimally processed whole grains | Experimental | Behavioral: Partial feeding studyPartial feeding study |
| Highly processed whole grains | Experimental | Behavioral: Partial feeding studyPartial feeding study |
| Refined grains | Active comparator | Behavioral: Partial feeding studyPartial feeding study |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18 to 35 years
- Body mass index ≥ 25 and <40 kg/m2
- Serum fasting insulin >10 uIU/mL and one of the following metabolic syndrome components: waist circumference, men: ≥102 cm, women: ≥88 cm; triglycerides, ≥150 mg/dL; HDL-C, men: <40 mg/dL , women: <50 mg/dL; systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg; or fasting glucose, ≥100 mg/dL
- Medical clearance from a primary care provider to rule out any major medical illness, disability, or disorder (e.g., liver disease, renal failure, cancer)
- Access to a working telephone or cell phone
Key exclusion criteria (13 listed)
- Pre-existing major medical illness by medical history or laboratory screening tests
- Allergy or sensitivity to gluten (self-reported or physician diagnosed)
- >5% change in weight within previous 6 months
- Current smoking (1 cigarette in the past week)
- Major surgery within the previous 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 |
|---|---|---|
| Partial feeding studyProvision of all grain foods where only the processing of kernels used to produce the grain foods will differ among test diets. Each participant will be assigned to complete the three 4-week test diets in random sequence. | Behavioural | Highly processed whole grains, Intact/minimally processed whole grains, Refined grains |
Primary outcome
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
51 secondary outcomes
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting glucose at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in fasting insulin at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood lipids at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in high-sensitivity C-reactive protein at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in alanine aminotransferase (ALT) at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in serum metabolomics profile at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in blood pressure at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in waist circumference at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 8
Time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of hunger and satiation at week 12
Time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 4
Time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Julia MW Wong, PhD, RD principal investigator
Boston Children's Hospital
David S Ludwig, MD, PhD study chair
Boston Children's Hospital
Cara B Ebbeling, PhD study chair
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial feeding study in people with Insulin Resistance and Cardiovascular Disease, run by Boston Children's Hospital 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 13 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: withdrawn, as of the sponsor's last update on 11 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4 (time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)). The study lists 3 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 11 Apr 2017.