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Processing Responses of Grains (PRO-Grains) Study

Primary Purpose

Insulin Resistance, Cardiovascular Disease, Diabetes

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Partial feeding study

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Whole grains, Food processing, Cardiometabolic risk factors

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.
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)

Sites / Locations

Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Intact/minimally processed whole grains

Highly processed whole grains

Refined grains

Arm Description

Partial feeding study

Outcomes

Primary Outcome Measures

Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4

Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8

Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12

Secondary Outcome Measures

Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4

Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8

Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12

Change from week 0 in fasting glucose at week 4

Change from week 0 in fasting glucose at week 8

Change from week 0 in fasting glucose at week 12

Change from week 0 in fasting insulin at week 4

Change from week 0 in fasting insulin at week 8

Change from week 0 in fasting insulin at week 12

Change from week 0 in blood lipids at week 4

Change from week 0 in blood lipids at week 8

Change from week 0 in blood lipids at week 12

Change from week 0 in high-sensitivity C-reactive protein at week 4

Change from week 0 in high-sensitivity C-reactive protein at week 8

Change from week 0 in high-sensitivity C-reactive protein at week 12

Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 4

Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 8

Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 12

Change from week 0 in alanine aminotransferase (ALT) at week 4

Change from week 0 in alanine aminotransferase (ALT) at week 8

Change from week 0 in alanine aminotransferase (ALT) at week 12

Change from week 0 in serum metabolomics profile at week 4

Change from week 0 in serum metabolomics profile at week 8

Change from week 0 in serum metabolomics profile at week 12

Change from week 0 in blood pressure at week 4

Change from week 0 in blood pressure at week 8

Change from week 0 in blood pressure at week 12

Change from week 0 in waist circumference at week 4

Change from week 0 in waist circumference at week 8

Change from week 0 in waist circumference at week 12

Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 4

Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 8

Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 12

Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 4

Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 8

Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 12

Change from week 0 in ratings of hunger and satiation at week 4

Change from week 0 in ratings of hunger and satiation at week 8

Change from week 0 in ratings of hunger and satiation at week 12

Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 4

Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 8

Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 12

Change from week 0 in body weight at week 4

Change from week 0 in body weight at week 8

Change from week 0 in body weight at week 12

Change from week 0 in dietary intake at week 4

Change from week 0 in dietary intake at week 8

Change from week 0 in dietary intake at week 12

Change from week 0 in physical activity (assessed by accelerometry) at week 4

Change from week 0 in physical activity (assessed by accelerometry) at week 8

Change from week 0 in physical activity (assessed by accelerometry) at week 12

Full Information

NCT ID

NCT02186353

First Posted

June 17, 2014

Last Updated

April 10, 2017

Sponsor

Boston Children's Hospital

Collaborators

Kansas State University

1. Study Identification

Unique Protocol Identification Number

NCT02186353

Brief Title

Processing Responses of Grains (PRO-Grains) Study

Official Title

Effect of Intact vs. Highly Processed Whole Grains on Insulin Sensitivity and Other Cardiometabolic Risk Factors in Hyperinsulinemic Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of adequate funding

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

Kansas State University

4. Oversight

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Cardiovascular Disease, Diabetes

Keywords

Whole grains, Food processing, Cardiometabolic risk factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intact/minimally processed whole grains

Arm Type

Experimental

Arm Description

Partial feeding study

Arm Title

Highly processed whole grains

Arm Type

Experimental

Arm Description

Partial feeding study

Arm Title

Refined grains

Arm Type

Active Comparator

Arm Description

Partial feeding study

Intervention Type

Behavioral

Intervention Name(s)

Partial feeding study

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) 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)

Title

Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) 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)

Title

Change from week 0 in body weight 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)

Title

Change from week 0 in body weight 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)

Title

Change from week 0 in body weight 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)

Title

Change from week 0 in dietary intake 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)

Title

Change from week 0 in dietary intake 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)

Title

Change from week 0 in dietary intake 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)

Title

Change from week 0 in physical activity (assessed by accelerometry) 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)

Title

Change from week 0 in physical activity (assessed by accelerometry) 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)

Title

Change from week 0 in physical activity (assessed by accelerometry) 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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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. 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julia MW Wong, PhD, RD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David S Ludwig, MD, PhD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Cara B Ebbeling, PhD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Children's Hospital Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Processing Responses of Grains (PRO-Grains) Study

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