Processing Responses of Grains (PRO-Grains) Study

Withdrawn before enrolling · Not applicable

Conditions studied: Insulin Resistance, Cardiovascular Disease, Diabetes

In brief

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.

Key facts

Study ID

NCT02186353

Run by

Boston Children's Hospital

People needed

0

Starts

2014-09-01

Expected to finish

2015-09-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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