Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control

NCT04171648 | Terminated

• 1 other identifier: 19049
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Glycemic Control

Keywords

diet management; weight management

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Blood Glucose Response (Glycemic Response)

  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]

Secondary Outcomes (2)

• weight change

  Once week one, once week 4, once week 8.

• waist to hip ratio

  Once week one, once week 4, once week 7.

Study Arms (2)

Roasted Peanut Group 1

EXPERIMENTAL

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; Other: Boiled Peanut Treatment

Boiled Peanut Group 1

EXPERIMENTAL

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; Other: Boiled Peanut Treatment

Interventions

Roasted Peanut Treatment OTHER

The subjects will consume 2 ounces or \~48 grams of roasted in shell peanuts a day for two weeks.

Boiled Peanut Group 1; Roasted Peanut Group 1

Boiled Peanut Treatment OTHER

The subjects will consume 2 ounces or \~48 grams of boiled peanuts a day for two weeks.

Boiled Peanut Group 1; Roasted Peanut Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Carolina State University: lead

Study Sites (1)

North Carolina State University

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathan C Allen, PhD

  North Carolina State University

  STUDY CHAIR

• Lisa Dean, PhD

  USDA ARS - Market Quality and Handling Unit, North Carolina State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science Nutrition (Thesis) Graduate Student

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: March 2, 2020
• Primary Completion: March 17, 2020
• Study Completion: March 18, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)