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Walnuts and Glucose Variability

NCT01787214 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-03-18

No results posted yet for this study

Summary

Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.

Conditions

  • Type-2 Diabetes

Interventions

DIETARY_SUPPLEMENT

Full dose

20% of daily energy needs supplied by walnuts

DIETARY_SUPPLEMENT

Half dose

10% of daily energy needs supplied by walnuts

DIETARY_SUPPLEMENT

Control

Walnut free meals

Sponsors & Collaborators

  • California Walnut Commission

    collaborator OTHER

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Michelle Wien, DrPH, RD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01787214 on ClinicalTrials.gov