NCT03495284

Brief Summary

A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.

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 not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2020

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

January 15, 2018

Last Update Submit

August 15, 2023

Conditions

Type 2 Diabetes MellitusCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Fasting blood glucose

    4 weeks

Secondary Outcomes (12)

  • Homeostasis Model of Assessment of Insulin Resistance

    4 weeks

  • Peripheral blood pressure

    4 weeks

  • Central blood pressure

    4 weeks

  • Total cholesterol

    4 weeks

  • Pulse Wave Velocity

    4 weeks

  • +7 more secondary outcomes

Study Arms (2)

Potato treatment

EXPERIMENTAL

Participants will be provided with one potato-based side dish, equivalent to one medium sized potato, every day for 4 weeks for incorporation into their self-selected diet. The potato-based side dish will be prepared at the Penn State Metabolic Kitchen. The potato side dish will consist of commonly consumed potato-based sides in the U.S. and there will be limited inclusion of ingredients high in saturated fat, refined sugars or sodium. French fries will not be provided. The variety of potatoes will represent consumption patterns in the U.S. including white, russet, yellow and red potatoes.

Dietary Supplement: Potato-based side dish

Refined grain treatment

ACTIVE COMPARATOR

Participants will be provided with a calorie-matched refined grain-based side dish every day for 4 weeks for incorporation into their self-selected diet. The refined grain-based side dishes will be prepared at the Penn State Metabolic Kitchen and ingredients high in saturated fat, refined sugar or sodium will not be used. These will be sides commonly eaten in the U.S. (e.g. pasta made with white flour and white rice, white bread rolls). During this treatment, participants will be told not to consume potatoes.

Dietary Supplement: Refined grain-based

Interventions

Potato-based side dishDIETARY_SUPPLEMENT

Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks

Potato treatment
Refined grain-basedDIETARY_SUPPLEMENT

Daily consumption of an isocaloric refined grain-based side dish for 4 weeks

Refined grain treatment

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking
  • BMI \> 20 and \<40 kg/m2
  • Male or female

You may not qualify if:

  • Diagnosed diabetes or fasting glucose \>126 mg/dl
  • Hypertension (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Penny M Kris-Etherton, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

April 11, 2018

Study Start

February 19, 2018

Primary Completion

May 19, 2019

Study Completion

January 19, 2020

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)