Almonds and Diabetes Management

NCT01161030 | Completed

• 1 other identifier: almond1
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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 Arms (2)

almonds

EXPERIMENTAL

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

Dietary Supplement: Almonds

Control

PLACEBO COMPARATOR

cheese stick

Dietary Supplement: Almonds

Interventions

Almonds DIETARY_SUPPLEMENT

Control; almonds

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
• 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.

You may not qualify if:

• Insulin use
• History of a peanut allergy
• Chronic or unresolved disease
• Current smoking habit
• Pregnant or lactating
• Medication use that may impact incretin secretion. \[Incretins are gastrointestinal hormones secreted at meal-time.\]

Sponsors & Collaborators

• Arizona State University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 28, 2019

Record last verified: 2019-08