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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270985
• Other study ID #: 0120050322
• Status: Completed
• Phase: Phase 1
• First received: December 27, 2005
• Last updated: June 20, 2016
• Start date: January 2006
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2016
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Almonds in a calorie controlled diet
Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes
• Nut free diet
Calorie controlled diet free of nuts for adults with pre-type 2 diabetes

Locations

Country	Name	City	State
United States	UMDNJ	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Almond Board of California

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control	16 weeks	No
Secondary	hs-CRP	change in high sensitivity C Reactive Protein as an indication of inflammation over course of the intervention	16 wks	No
Secondary	Il-6	Change in Interleukin 6 over the 16 week intervention as an indication of inflammation/metabolic syndrome	16 weeks	No