Processing Responses of Grains (PRO-Grains) Study

NCT02186353 | Withdrawn

• 1 other identifier: P00009343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Cardiovascular Disease; Diabetes

Keywords

Whole grains; Food processing; Cardiometabolic risk factors

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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

  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

  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

  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

  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

  Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)

Study Arms (3)

Intact/minimally processed whole grains

EXPERIMENTAL

Partial feeding study

Behavioral: Partial feeding study

Highly processed whole grains

EXPERIMENTAL

Partial feeding study

Behavioral: Partial feeding study

Refined grains

ACTIVE COMPARATOR

Partial feeding study

Behavioral: Partial feeding study

Interventions

Partial feeding study BEHAVIORAL

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.

Highly processed whole grains; Intact/minimally processed whole grains; Refined grains

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Kansas State University: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Julia MW Wong, PhD, RD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  STUDY CHAIR

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Pediatrics

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: July 10, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)