Cardiovascular Diseases, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPotato-based side dish
Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
DIETARY_SUPPLEMENTRefined grain-based
Daily consumption of an isocaloric refined grain-based side dish for 4 weeks
Sponsors
Alliance for Potato Research and Education
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood pressure | 4 weeks |
| Central blood pressure | 4 weeks |
| Total cholesterol | 4 weeks |
| Pulse Wave Velocity | 4 weeks |
| Augmentation index | 4 weeks |
| Homeostasis Model of Assessment of Insulin Resistance | 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 |
| 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 |
| LDL cholesterol | 4 weeks |
| HDL cholesterol | 4 weeks |
| Triglycerides | 4 weeks |
| Diet quality measured by the Healthy Eating Index 2010 | 4 weeks |
Countries
United States
Outcome results
None listed