Clinical trial NCT01787214: Walnuts and Glucose Variability
Official title: The Effect of Walnuts on Glucose Variability in Adults With Type-2 Diabetes Mellitus: a Dose-response Metabolic Feeding Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type-2 Diabetes
Keywords: glucose variability
glycemia
type-2 diabetes
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: California Walnut Commission
First posted: 2013-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Within-day glucose variability
timeFrame: 3 days
Secondary outcomes:
measure: Glucose variability dose response
timeFrame: 3 days
measure: Dose response to between-day glycemic variability
timeFrame: 3 days
measure: Glucose levels by meal
timeFrame: 3 days
measure: Mean glucose of sensor range
timeFrame: 3 days
measure: Duration of hypoglycemia
timeFrame: 3 days
measure: Duration of hyperglycemia
timeFrame: 3 days
measure: Net glycemia at 2 hours
timeFrame: 3 days
measure: Net glycemia at 4 hours
timeFrame: 3 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, Nichol Hall
state: California
Study officials:
affiliation: Assistant Professor
name: Michelle Wien, DrPH, RD
role: PRINCIPAL_INVESTIGATOR
References: