Status:
WITHDRAWN
Processing Responses of Grains (PRO-Grains) Study
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Kansas State University
Conditions:
Insulin Resistance
Cardiovascular Disease
Eligibility:
All Genders
18-35 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02186353
Start Date
September 1 2014
End Date
September 1 2015
Last Update
April 11 2017
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115