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OpenTrials
Completed

NCT Number: NCT01161030

Almonds and Diabetes Management

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).

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.]

Treatment and study plan

Almonds

Dietary Supplement

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 13, 2010
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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