Walnuts and Glucose Variability

NCT ID: NCT01787214

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type-2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Full dose

full dose of walnuts (20% energy needs)

Group Type ACTIVE_COMPARATOR

Full dose

Intervention Type DIETARY_SUPPLEMENT

20% of daily energy needs supplied by walnuts

Half-dose

Half dose of walnuts (10% of energy needs)

Group Type ACTIVE_COMPARATOR

Half dose

Intervention Type DIETARY_SUPPLEMENT

10% of daily energy needs supplied by walnuts

Control

Walnut free meals

Group Type OTHER

Control

Intervention Type DIETARY_SUPPLEMENT

Walnut free meals

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Full dose

20% of daily energy needs supplied by walnuts

Intervention Type DIETARY_SUPPLEMENT

Half dose

10% of daily energy needs supplied by walnuts

Intervention Type DIETARY_SUPPLEMENT

Control

Walnut free meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adults between age 40 and 70 years with type 2 diabetes
* duration of type 2 diabetes more than 6 months but less than 10 years
* HbA1c 6.0-8.0%
* BMI 25-40 kg/m2
* diet controlled or stable dose of metformin for at least 3 months
* willing to test blood glucose with personal meter twice a day during study test days

Exclusion Criteria

* using oral hypoglycemic agents or insulin
* history of ischemic heart disease or congestive heart failure
* history of severe diabetic complication (neuropathy, renal failure, stroke)
* taking medication affecting glucose levels (i.e. corticosteroids)
* active infectious disease
* active malignancy
* pregnant or breast feeding woman
* smoker
* history of daily caffeine or alcohol intake
* known allergy to nuts
* lactose or gluten intolerance
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Walnut Commission

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle Wien

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michelle Wien, DrPH, RD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University, Nichol Hall

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

walnuts and glucose

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-meal Protein Drink Improve Glycemic Regulation
NCT01987674 TERMINATED PHASE1/PHASE2
Peanuts and Glycemic Control
NCT03654651 COMPLETED PHASE2