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Almonds and Diabetes Management

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Almonds
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 9, 2010
    Last Updated
    August 24, 2019
    Sponsor
    Arizona State University
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    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

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    Almonds and Diabetes Management

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