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

NCT00270985 | Completed Phase 1

• 1 other identifier: 0120050322
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes; Insulin Resistance; Metabolic Syndrome

Keywords

almonds; pre-diabetes; inflammatory; CRP

Outcome Measures

Primary Outcomes (1)

• HbA1c

  change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control

  16 weeks

Secondary Outcomes (2)

• hs-CRP

  16 wks

• Il-6

  16 weeks

Study Arms (2)

nut free diet

ACTIVE COMPARATOR

ADA recommended diabetes diet without any nuts

Behavioral: Nut free diet

almond group

EXPERIMENTAL

calorie controlled diet with prescribed daily amount of almonds

Behavioral: Almonds in a calorie controlled diet

Interventions

Almonds in a calorie controlled diet BEHAVIORAL

Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes

almond group

Nut free diet BEHAVIORAL

Calorie controlled diet free of nuts for adults with pre-type 2 diabetes

nut free diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Almond Board of California: collaborator

Study Sites (1)

UMDNJ

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Wien M, Bleich D, Raghuwanshi M, Gould-Forgerite S, Gomes J, Monahan-Couch L, Oda K. Almond consumption and cardiovascular risk factors in adults with prediabetes. J Am Coll Nutr. 2010 Jun;29(3):189-97. doi: 10.1080/07315724.2010.10719833.

  PMID: 20833991 RESULT

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Metabolic Syndrome; Glucose Intolerance

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan E Gould Fogerite, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 29, 2005
• Study Start: January 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)