Effects of a Mediterranean Diet with Potatoes on Heart and Metabolic Health in Adults with Pre-Diabetes
Effects of a Mediterranean Dietary Pattern With White Potato on Cardiometabolic Health in Adults With Pre-Diabetes
This study is testing if adding baked potatoes to a Mediterranean diet can help adults with pre-diabetes improve their heart and metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | University of Nevada, Las Vegas Academic / other |
| Locations | 2 sites (Las Vegas, Nevada and 1 other locations) |
| Trial ID | NCT06817252 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of incorporating baked potatoes with skin into a Mediterranean dietary pattern, combined with nutrition education, on glycemic control and cardiometabolic health in adults aged 45 to 80 with pre-diabetes. Participants will be randomly assigned to receive either the Mediterranean diet with baked potatoes or the Mediterranean diet alone over a 12-week period. The study will assess various health indicators, including blood lipids, inflammation, and dietary quality, to determine the effectiveness of the intervention. Recruitment will focus on individuals from diverse demographic backgrounds in the Las Vegas area.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 45-80 with a BMI between 25-40 and fasting blood glucose levels indicative of pre-diabetes.
Not a fit: Patients with uncontrolled hypertension, active cancer, or those currently using insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations for managing pre-diabetes and enhancing heart health.
How similar studies have performed: Previous studies have shown positive outcomes with Mediterranean dietary patterns, but the specific combination with baked potatoes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and postmenopausal women within the Las Vegas/Henderson NV area * Ages 45-80 years * BMI between 25-40 kg/m2 * HbA1c between 5.7-6.4% * Individuals from different demographic backgrounds (i.e., American Indian or Alaska Native, Caucasians, Asian, Black or African-American, Native Hawaiian, Hispanic, Latino or Pacific Islander) * Individuals who are considered "non-frequent" white potato consumers (\<2 servings of baked potatoes/week) * Individuals from all races, genders, sexual identities, and religions will be included * Individuals must follow certain guidelines, including avoiding new medications during the study or significant changes to lifestyle factors (e.g. beginning to smoke or exercise more or less than usual) Exclusion Criteria: * Individuals with uncontrolled hypertension (≥160/100mmHg), active cancer, asthma, thyroid, kidney, liver, or pancreatic diseases * Individuals who are currently using insulin, on dialysis, changing/adding hypoglycemic, anti-hypertensive, and hypocholesterolemic medication within ≤3 months (or throughout the study) * Individuals participating in weight loss programs or another clinical trial * Individuals who start smoking * Individuals who have unstable metabolic or chronic diseases * Individuals who may have allergies to potatoes * Woman who are currently pregnant, think they may be pregnant, or who is nursing cannot participate (women must be postmenopausal)
Where this trial is running
Las Vegas, Nevada and 1 other locations
- Department of Kinesiology and Nutrition Sciences — Las Vegas, Nevada, United States (Not_yet_recruiting)
- University of Nevada Las Vegas — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Principal investigator: Neda S Akhavan, PhD, RD — University of Nevada, Las Vegas
- Study coordinator: Neda S Akhavan, PhD, RD
- Email: neda.akhavan@UNLV.edu
- Phone: 702-708-2580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.