Clinical trial NCT03495284: The Effect of Potatoes on Markers of Cardiometabolic Health
Official title: The Effect of Potatoes on Markers of Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Alliance for Potato Research and Education
First posted: 2018-04-11
Enrollment: 51
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: 4 weeks
Secondary outcomes:
measure: Homeostasis Model of Assessment of Insulin Resistance
timeFrame: 4 weeks
measure: Peripheral blood pressure
timeFrame: 4 weeks
measure: Central blood pressure
timeFrame: 4 weeks
measure: Total cholesterol
timeFrame: 4 weeks
measure: Pulse Wave Velocity
timeFrame: 4 weeks
measure: Augmentation index
timeFrame: 4 weeks
measure: Diet quality measured by the Healthy Eating Index 2010
timeFrame: 4 weeks
measure: Change in fecal short chain fatty acid levels
timeFrame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
measure: Change in microbiome composition
timeFrame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
measure: LDL cholesterol
timeFrame: 4 weeks
measure: HDL cholesterol
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 4 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References: