- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270985
The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- UMDNJ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: nut free diet
ADA recommended diabetes diet without any nuts
|
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
|
Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 16 weeks
|
change in HbA1c over the course of 16 wk intervention as an indication of blood glucose control
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hs-CRP
Time Frame: 16 wks
|
change in high sensitivity C Reactive Protein as an indication of inflammation over course of the intervention
|
16 wks
|
Il-6
Time Frame: 16 weeks
|
Change in Interleukin 6 over the 16 week intervention as an indication of inflammation/metabolic syndrome
|
16 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan E Gould Fogerite, PhD, Rutgers, the State University of New Jersey
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120050322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome
-
Universidad de los Andes, ChileCompleted
-
Mayo ClinicCompleted
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on Nut free diet
-
USDA Beltsville Human Nutrition Research CenterCompleted
-
Loma Linda UniversityCompletedHeart Diseases | Inflammation | Cardiovascular Risk FactorUnited States
-
Monash UniversityRecruiting
-
Shahid Beheshti UniversityShahid Beheshti University of Medical SciencesCompletedCardiovascular Risk FactorIran, Islamic Republic of
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompletedObesity | OverweightIran, Islamic Republic of
-
Tufts UniversityNational Pecan Shellers AssociationCompletedCardiovascular Disease Risk | Type 2 Diabetes RiskUnited States
-
University of California, DavisWithdrawnHealthy | Overweight | Obese | Normal WeightUnited States
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompleted
-
University of California, DavisActive, not recruitingCardiovascular DiseasesUnited States
-
Hospital General Universitario Reina Sofía de MurciaCompletedDiet Modification | Diverticulitis | Dietary Modification | Diverticulitis, Colonic | Acute Diverticulitis | Uncomplicated Diverticular Disease | Diverticulitis of SigmoidSpain