Walnuts and Glucose Variability
Primary Purpose
Type-2 Diabetes
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full dose
Half dose
Control
Sponsored by
About this trial
This is an interventional treatment trial for Type-2 Diabetes focused on measuring glucose variability, glycemia, type-2 diabetes
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
Sites / Locations
- Loma Linda University, Nichol Hall
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Full dose
Half-dose
Control
Arm Description
full dose of walnuts (20% energy needs)
Half dose of walnuts (10% of energy needs)
Walnut free meals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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)
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
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)
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)
Net glycemia at 2 hours
The continuous overall net glycemic action will be measured at 2 hour intervals
Net glycemia at 4 hours
The continuous overall net glycemic action will be measured at 4 hour intervals
Full Information
NCT ID
NCT01787214
First Posted
February 1, 2013
Last Updated
March 17, 2014
Sponsor
Loma Linda University
Collaborators
California Walnut Commission
1. Study Identification
Unique Protocol Identification Number
NCT01787214
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Funding withdrawn
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
California Walnut Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2 Diabetes
Keywords
glucose variability, glycemia, type-2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full dose
Arm Type
Active Comparator
Arm Description
full dose of walnuts (20% energy needs)
Arm Title
Half-dose
Arm Type
Active Comparator
Arm Description
Half dose of walnuts (10% of energy needs)
Arm Title
Control
Arm Type
Other
Arm Description
Walnut free meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Full dose
Intervention Description
20% of daily energy needs supplied by walnuts
Intervention Type
Dietary Supplement
Intervention Name(s)
Half dose
Intervention Description
10% of daily energy needs supplied by walnuts
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Walnut free meals
Primary Outcome Measure Information:
Title
Within-day glucose variability
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Glucose variability dose response
Description
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.
Time Frame
3 days
Title
Dose response to between-day glycemic variability
Description
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
Time Frame
3 days
Title
Glucose levels by meal
Description
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)
Time Frame
3 days
Title
Mean glucose of sensor range
Description
The mean of the glucose for the range captured on each sensor (sensor maximal glucose level minus minimal glucose level will be recorded
Time Frame
3 days
Title
Duration of hypoglycemia
Description
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)
Time Frame
3 days
Title
Duration of hyperglycemia
Description
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)
Time Frame
3 days
Title
Net glycemia at 2 hours
Description
The continuous overall net glycemic action will be measured at 2 hour intervals
Time Frame
3 days
Title
Net glycemia at 4 hours
Description
The continuous overall net glycemic action will be measured at 4 hour intervals
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Wien, DrPH, RD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University, Nichol Hall
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
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Walnuts and Glucose Variability
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