Almonds and Diabetes Management

NCT ID: NCT01161030

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-11-30

Brief Summary

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).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

almonds

1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat

Group Type: EXPERIMENTAL

Almonds

Intervention Type: DIETARY_SUPPLEMENT

Control

cheese stick

Group Type: PLACEBO_COMPARATOR

Almonds

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Almonds

Intervention Type: DIETARY_SUPPLEMENT

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.]

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

almond1

Identifier Type: -

Identifier Source: org_study_id