Status:
COMPLETED
The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Almond Board of California
Conditions:
Prediabetes
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study Hypothesis: Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes. Lay Summary: Persons developing type 2 diabetes me...
Detailed Description
Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes. Lay Summary: Persons developing type 2 diabetes mellitus (T2DM) will ...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- No self-reported allergy to almonds
- No history of irritable bowel disease or diverticulitis that could be exacerbated by daily almond intake
- Presence of pre-diabetes according to the 2005 American Diabetes Association diagnostic guidelines (fasting blood glucose between 100 to 125 mg/dl or casual blood glucose ≥ 140-199 mg/dl)
- Body mass index (BMI) 20-35 kg/m2 to enhance the generalizability of the study's findings to the population of adults with pre-diabetes
- Willingness to discontinue vitamin E supplement usage while enrolled in the study.
Exclusion
- No concurrent use of corticosteroids or immunosuppressant medications (tacrolimus, cyclosporine, sirolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, everolimus) in light of their effect on inflammatory biomarkers
- No liver disease, renal disease and/or severe dyslipidemia (triglycerides \[TG\] \> 400mg/dl or total cholesterol \[TC\] \> 300 mg/dl)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00270985
Start Date
January 1 2006
End Date
June 1 2016
Last Update
June 22 2016
Active Locations (1)
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1
UMDNJ
Newark, New Jersey, United States, 07103