- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161030
Almonds and Diabetes Management
August 24, 2019 updated by: Carol Johnston, Arizona State University
Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: almonds
1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat
|
|
Placebo Comparator: Control
cheese stick
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
July 9, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 24, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- almond1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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