Walnuts and Glucose Variability

Loma Linda University (LLU)

Status: Terminated

Conditions: Type-2 Diabetes

Treatments: Dietary Supplement: Control; Dietary Supplement: Full dose; Dietary Supplement: Half dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01787214

walnuts and glucose

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 3 patient groups

Full dose

Active Comparator group

Description:

full dose of walnuts (20% energy needs)

Treatment:

Dietary Supplement: Full dose

Half-dose

Active Comparator group

Description:

Half dose of walnuts (10% of energy needs)

Treatment:

Dietary Supplement: Half dose

Control

Other group

Description:

Walnut free meals

Treatment:

Dietary Supplement: Control