The Effect of Potatoes on Markers of Cardiometabolic Health

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Cardiovascular Diseases

• Registration Number: NCT03495284
• Lead Sponsor: Penn State University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-15
• Study Start: 2018-02-19
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Primary Completion: 2019-05-19
• Study Completion: 2020-01-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose	4 weeks

Secondary Outcome Measures

Name	Time	Method
LDL cholesterol	4 weeks
Change in fecal short chain fatty acid levels	Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Homeostasis Model of Assessment of Insulin Resistance	4 weeks
Peripheral blood pressure	4 weeks
Central blood pressure	4 weeks
Triglycerides	4 weeks
Total cholesterol	4 weeks
Pulse Wave Velocity	4 weeks
Diet quality measured by the Healthy Eating Index 2010	4 weeks
Change in microbiome composition	Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
HDL cholesterol	4 weeks
Augmentation index	4 weeks

Trial Locations

Locations (1)

Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States