Walnuts and Glucose Variability

Type-2 Diabetes Clinical Trial

Official title:

The Effect of Walnuts on Glucose Variability in Adults With Type-2 Diabetes Mellitus: a Dose-response Metabolic Feeding Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01787214
• Other study ID #: walnuts and glucose
• Status: Terminated
• Phase: N/A
• First received: February 1, 2013
• Last updated: March 17, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type-2 Diabetes

Intervention

Dietary Supplement:
• Full dose
20% of daily energy needs supplied by walnuts
• Half dose
10% of daily energy needs supplied by walnuts
• Control
Walnut free meals

Locations

Country	Name	City	State
United States	Loma Linda University, Nichol Hall	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	California Walnut Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-day glucose variability	The primary objective is to evaluate the effect of two isocaloric walnut-enriched meal plans versus a walnut-free ADA meal plan on within-day glucose variability in adults with diabetes by assessing: a) the overall standard deviation (SD) around the sensor glucose calculated for each day and then averaged over the 3-day study periods; b) the mean amplitude of glycemic excursions (MAGE) over the 3-day study periods.	3 days	No
Secondary	Glucose variability dose response	A secondary objective will be to test for a dose-response effect, i.e. the more walnuts (full-dose versus half-dose) the lower the glucose variability.	3 days	No
Secondary	Dose response to between-day glycemic variability	The effect of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free) on the mean of the daily differences(MODD) will be recorded as a measure of between-day glycemic variability	3 days	No
Secondary	Glucose levels by meal	Glucose levels will be measured before and after breakfast, lunch and dinner for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)	3 days	No
Secondary	Mean glucose of sensor range	The mean of the glucose for the range captured on each sensor (sensor maximal glucose level minus minimal glucose level will be recorded	3 days	No
Secondary	Duration of hypoglycemia	The duration of hypoglycemia will be measured as hours per day for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)	3 days	No
Secondary	Duration of hyperglycemia	The duration of hyperglycemia will be measured as hours per day for each of the three isocaloric ADA meal plans (full-dose, half-dose, walnut free)	3 days	No
Secondary	Net glycemia at 2 hours	The continuous overall net glycemic action will be measured at 2 hour intervals	3 days	No
Secondary	Net glycemia at 4 hours	The continuous overall net glycemic action will be measured at 4 hour intervals	3 days	No