The Effect of Potatoes on Markers of Cardiometabolic Health

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Diseases

Treatments: Dietary Supplement: Refined grain-based; Dietary Supplement: Potato-based side dish

Study type: Interventional

Funder types: Other

Identifiers

NCT03495284

PKE POTATO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Potato treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Potato-based side dish

Refined grain treatment

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Refined grain-based