- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171648
Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Raleigh, North Carolina, United States, 27607
- North Carolina State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women with ages 18 to 65
- BMI ranges [(in kg/m2) 18.5>24.9] from Raleigh-Durham area 3. We will not recruit pregnant women
Exclusion Criteria:
- BMI >24.9 kg/m2 or <18 kg/m2
- Type 1 or 2 diabetes
- Anemia
- Fasting glucose >125 mg/dL
- Use of medication that affect glucose metabolism, renal, liver, pancreatic, or cardiovascular disease.
- Uncontrolled hypertension
- Disorders of the esophageal or in gastrointestinal motility
- Hypo- or hyperthyroidism
- Allergy to peanuts
- Pregnancy.
- Body weight < 110 lb
- Insulin Resistance
- Polycystic Ovary Syndrome
- Food intolerances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Roasted Peanut Group 1
Arm 1 is the arm of participants that will receive the roasted peanut treatment first and then will crossover to the boiled peanut treatment.
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The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.
The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.
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Experimental: Boiled Peanut Group 1
Arm 2 is the arm of participants that will receive the boiled peanut treatment first then will crossover to the roasted peanut treatment.
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The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.
The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Blood Glucose Response (Glycemic Response)
Time Frame: [week 1 - phase 1 - three measurements mon/wed/fri] [week 2 - wash out week] [week 3 & week 4- phase 2 - one measurement at the end of week 4] [week 5 - wash out week] [week 6 & week 7 - phase 3 - one measurement at end of week 7]
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The blood glucose response will be measured during each oral glucose tolerance test. These tests will happen periodically through out the study to determine if there is any correlation and or significant difference in glycemic response between consuming boiled or roasted peanuts (acute and chronic consumption). The metric is the blood glucose concentration measured by a blood glucose monitor by finger prick 10 times over a two hour period after consuming a standardized 50 gram glucose beverage. The 10 blood glucose measurements are synthesized into one measurement to display a pattern of blood glucose concentrations called the glycemic response. Please refer to Study Description -Detailed Description for a more thorough explanation. |
[week 1 - phase 1 - three measurements mon/wed/fri] [week 2 - wash out week] [week 3 & week 4- phase 2 - one measurement at the end of week 4] [week 5 - wash out week] [week 6 & week 7 - phase 3 - one measurement at end of week 7]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight change
Time Frame: Once week one, once week 4, once week 8.
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Weight of each participant will be measured to determine any weight loss or gain during the study.
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Once week one, once week 4, once week 8.
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waist to hip ratio
Time Frame: Once week one, once week 4, once week 7.
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Waist to hip ration of each participant will be measured to further define any weight change during the study.
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Once week one, once week 4, once week 7.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jonathan C Allen, PhD, North Carolina State University
- Study Director: Lisa Dean, PhD, USDA ARS - Market Quality and Handling Unit, North Carolina State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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