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Almonds and Diabetes Management

This study has been completed.
Sponsor:
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01161030
First received: July 9, 2010
Last updated: July 12, 2010
Last verified: July 2010
History of Changes
  Purpose

This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:

  1. 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.
  2. 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
  3. 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).

Condition Intervention
Type 2 Diabetes
 Other: almonds

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arizona State University:

Enrollment: 32
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: almonds Other: almonds

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.]
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Carol Johnston, Arizona State University
ClinicalTrials.gov Identifier: NCT01161030     History of Changes
Other Study ID Numbers: almond1
Study First Received: July 9, 2010
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013