The Effect of Potatoes on Markers of Cardiometabolic Health

NCT ID: NCT03495284

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2020-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Potato treatment

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.

Group Type EXPERIMENTAL

Potato-based side dish

Intervention Type DIETARY_SUPPLEMENT

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

Refined grain treatment

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.

Group Type ACTIVE_COMPARATOR

Refined grain-based

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Potato-based side dish

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

Intervention Type DIETARY_SUPPLEMENT

Refined grain-based

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alliance for Potato Research and Education

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Penny M Kris-Etherton, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PKE POTATO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mediterranean Diet and Blood Sugar Study
NCT07229781 NOT_YET_RECRUITING NA
Tasting Plant Forward Meals
NCT07202988 NOT_YET_RECRUITING NA
Diet and Health in Adults With Metabolic Syndrome
NCT03935048 ACTIVE_NOT_RECRUITING NA