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Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control

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ClinicalTrials.gov Identifier: NCT04171648
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Brooke Wilson, North Carolina State University

Brief Summary:
Research on glycemic control related to nuts or whole snack foods has focused primarily on tree nuts. Different processing and cooking methods have not been comprehensively analyzed to observe the effect on nutrient quality, bioavailability, or digestive absorption in peanuts. There is little to no research surrounding the nutrition of boiled peanuts so it may be of interest to compare boiled to roasted peanuts in terms of glycemic control. Peanuts have been shown to have a similar beneficial effect on glycemic control while being more financially accessible than almonds. Glycemic control could be improved based on the low glycemic index, high fiber, lipid, and or protein content of peanuts. The acute trial (phase 1) will investigate the impact of preprandial peanut consumption on glycemic response. The participants will complete an oral glucose tolerance test for both roasted and boiled peanuts. The long term study (phase 2&3) consists of participants consuming one serving per day of boiled or roasted peanuts in a four week crossover trial to observe any long term impact of daily peanut snacking on glycemic control. (Wash out weeks occurring between all trials.) At the conclusion of phase 2 & 3 an oral glucose tolerance test will be executed. The subjects will self record a exercise/step count and diet dairy, weight and waist to hip ratio will be measured weekly. The study will aim for a male and/or female healthy population from 18-65 years of age at NCSU.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Glycemic Control Other: Roasted Peanut Treatment Other: Boiled Peanut Treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Half the subjects will receive the roasted peanut treatment and the other half will receive the boiled peanut treatment for two weeks, then both will have a week wash out, and then each group will switch to the opposite treatment for two weeks.
Masking: None (Open Label)
Masking Description: The nature of the participants eating (whole food) peanut samples roasted or boiled allows no way for the participants or the investigators to be masked from the two interventions. The care provider does not apply in this study and the outcomes assessor will be the same individual as the investigator.
Primary Purpose: Prevention
Official Title: Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.
Other: Roasted Peanut Treatment
The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.

Other: Boiled Peanut Treatment
The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.

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.
Other: Roasted Peanut Treatment
The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.

Other: Boiled Peanut Treatment
The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.




Primary Outcome Measures :
  1. 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] ]

    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.



Secondary Outcome Measures :
  1. weight change [ Time Frame: Once week one, once week 4, once week 8. ]
    Weight of each participant will be measured to determine any weight loss or gain during the study.

  2. waist to hip ratio [ Time Frame: Once week one, once week 4, once week 7. ]
    Waist to hip ration of each participant will be measured to further define any weight change during the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171648


Contacts
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Contact: Elizabeth B Wilson, MS 9196193309 ebwilso2@ncsu.edu
Contact: Jonathan C Allen, PhD 9195132257 jallen@ncsu.edu

Locations
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United States, North Carolina
North Carolina State University Recruiting
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
North Carolina State University
Investigators
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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 Documents (Full-Text)

Documents provided by Brooke Wilson, North Carolina State University:
Informed Consent Form  [PDF] November 11, 2019


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Responsible Party: Brooke Wilson, Master of Science Nutrition (Thesis) Graduate Student, North Carolina State University
ClinicalTrials.gov Identifier: NCT04171648     History of Changes
Other Study ID Numbers: 19049
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The de-identified individual participant data will not be shared unless the study is successful and is published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brooke Wilson, North Carolina State University:
diet management
weight management