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The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00270985
First received: December 27, 2005
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

Study Hypothesis:

Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes.

Lay Summary:

Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amounts of electrical current are available to study body fat. Body weight, waist and hip measurements, blood pressure and body composition testing will be performed at the start of the study and every 4 weeks during the study. Lastly, these other possible causes of heart disease and T2DM will be investigated to look at relationships with the substances in the blood.


Condition Intervention Phase
Prediabetes
Insulin Resistance
Metabolic Syndrome
 Behavioral: Almonds in a calorie controlled diet
Behavioral: Nut free diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control


Secondary Outcome Measures:
  • hs-CRP [ Time Frame: 16 wks ] [ Designated as safety issue: No ]
    change in high sensitivity C Reactive Protein as an indication of inflammation over course of the intervention

  • Il-6 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change in Interleukin 6 over the 16 week intervention as an indication of inflammation/metabolic syndrome


Enrollment: 66
Study Start Date: January 2006
Estimated Study Completion Date: July 2013
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nut free diet
ADA recommended diabetes diet without any nuts
 Behavioral: Nut free diet
Calorie controlled diet free of nuts for adults with pre-type 2 diabetes
Experimental: almond group
calorie controlled diet with prescribed daily amount of almonds
 Behavioral: Almonds in a calorie controlled diet
Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years
  • No self-reported allergy to almonds
  • No history of irritable bowel disease or diverticulitis that could be exacerbated by daily almond intake
  • Presence of pre-diabetes according to the 2005 American Diabetes Association diagnostic guidelines (fasting blood glucose between 100 to 125 mg/dl or casual blood glucose ≥ 140-199 mg/dl)
  • Body mass index (BMI) 20-35 kg/m2 to enhance the generalizability of the study's findings to the population of adults with pre-diabetes
  • Willingness to discontinue vitamin E supplement usage while enrolled in the study.

Exclusion Criteria:

  • No concurrent use of corticosteroids or immunosuppressant medications (tacrolimus, cyclosporine, sirolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, everolimus) in light of their effect on inflammatory biomarkers
  • No liver disease, renal disease and/or severe dyslipidemia (triglycerides [TG] > 400mg/dl or total cholesterol [TC] > 300 mg/dl)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270985

Locations
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Almond Board of California
Investigators
Principal Investigator: Susan E Gould Fogerite, PhD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00270985     History of Changes
Other Study ID Numbers: 0120050322
Study First Received: December 27, 2005
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
almonds
pre-diabetes
inflammatory
CRP

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Prediabetic State
Metabolic Syndrome X
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013