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Completed

NCT Number: NCT03495284

The Effect of Potatoes on Markers of Cardiometabolic Health

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potato-based side dish

Dietary Supplement

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

Refined grain-based

Dietary Supplement

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

Primary outcomes

  1. Fasting blood glucose

    Time frame: 4 weeks

Secondary outcomes

  1. Homeostasis Model of Assessment of Insulin Resistance

    Time frame: 4 weeks

  2. Peripheral blood pressure

    Time frame: 4 weeks

  3. Central blood pressure

    Time frame: 4 weeks

  4. Total cholesterol

    Time frame: 4 weeks

  5. Pulse Wave Velocity

    Time frame: 4 weeks

  6. Augmentation index

    Time frame: 4 weeks

  7. Diet quality measured by the Healthy Eating Index 2010

    Time frame: 4 weeks

  8. Change in fecal short chain fatty acid levels

    Time frame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4

  9. Change in microbiome composition

    Time frame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4

  10. LDL cholesterol

    Time frame: 4 weeks

  11. HDL cholesterol

    Time frame: 4 weeks

  12. Triglycerides

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Alliance for Potato Research and Education

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 11, 2018
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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