NCT03654651

Brief Summary

A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 13, 2022

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

August 29, 2018

Results QC Date

September 20, 2021

Last Update Submit

August 15, 2023

Conditions

Type2 DiabetesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Fasting Plasma Glucose

    Within-condition mean differences (change from baseline).

    6 weeks

Secondary Outcomes (12)

  • Fructosamine

    6 weeks

  • Fasting Insulin

    6 weeks

  • Peripheral Systolic and Diastolic Blood Pressure

    6 weeks

  • Central Systolic and Diastolic Blood Pressure

    6 weeks

  • Carotid Femoral Pulse Wave Velocity

    6 weeks

  • +7 more secondary outcomes

Study Arms (2)

Evening Peanut Consumption

EXPERIMENTAL

Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).

Drug: Peanut

Evening Snack

ACTIVE COMPARATOR

Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).

Drug: High carbohydrate snack

Interventions

PeanutDRUG

Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.

Evening Peanut Consumption
High carbohydrate snackDRUG

Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).

Evening Snack

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking
  • Impaired fasting glucose at screening (≥ 100 mg/dL).
  • BMI ≥20 and ≤40 kg/m2.

You may not qualify if:

  • Diagnosed diabetes or fasting glucose \>126 mg/dl
  • Systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
  • Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
  • Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
  • Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
  • Pregnancy or lactation
  • Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
  • Smoking or use of any tobacco products
  • Allergy to test foods
  • Consumption of \>14 alcoholic drinks/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Sapp PA, Kris-Etherton PM, Petersen KS. Peanuts or an Isocaloric Lower Fat, Higher Carbohydrate Nighttime Snack Have Similar Effects on Fasting Glucose in Adults with Elevated Fasting Glucose Concentrations: a 6-Week Randomized Crossover Trial. J Nutr. 2022 Jan 11;152(1):153-162. doi: 10.1093/jn/nxab347.

    PMID: 34562081DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

Title
Dr. Penny Kris-Etherton
Organization
The Pennsylvania State University
pmk3@psu.edu
814-863-2923

Study Officials

  • Penny M Kris-Etherton, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Kristina S Petersen, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

October 1, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

August 18, 2023

Results First Posted

May 13, 2022

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)