Back to resultsAlmonds and Diabetes Management
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Almonds
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
- 24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
- Subjects from the campus population and nearby communities will be recruited to participate in these trials.
Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:
- subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
- participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
- Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
- Subjects with T2D may take oral hyperglycemic agents.
Exclusion Criteria:
- Insulin use
- History of a peanut allergy
- Chronic or unresolved disease
- Current smoking habit
- Pregnant or lactating
- Medication use that may impact incretin secretion. [Incretins are gastrointestinal hormones secreted at meal-time.]
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
almonds
Control
Arm Description
1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat
cheese stick
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01161030
Brief Title
Almonds and Diabetes Management
Official Title
Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:
Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
almonds
Arm Type
Experimental
Arm Description
1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
cheese stick
Intervention Type
Dietary Supplement
Intervention Name(s)
Almonds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
Subjects from the campus population and nearby communities will be recruited to participate in these trials.
Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:
subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
Subjects with T2D may take oral hyperglycemic agents.
Exclusion Criteria:
Insulin use
History of a peanut allergy
Chronic or unresolved disease
Current smoking habit
Pregnant or lactating
Medication use that may impact incretin secretion. [Incretins are gastrointestinal hormones secreted at meal-time.]
12. IPD Sharing Statement
Learn more about this trial
Almonds and Diabetes Management
We'll reach out to this number within 24 hrs