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NCT Number: NCT03935048

Diet and Health in Adults With Metabolic Syndrome

The prevalence of US adults with Metabolic Syndrome (MetS) is over 34%, impacting nearly 35% of all adults and 50% of those aged 60 years or older. MetS is characterized as a combination of underlying risk factors that when, occurring together, increase the risk for chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease, stroke, and certain types of cancer, resulting in an 1.6-fold increase in mortality. According the American Heart Association, health risks associated with Metabolic Syndrome can be significantly reduced by reducing body weight and eating a diet that is rich in whole grains, fruits, and vegetables. Potatoes (e.g. skin-on white potatoes) are an excellent source of potassium, vitamin C, and vitamin B6 and a good source of magnesium and dietary fiber. In addition, the potato has greater dry matter and protein per unit growing area compared with cereals. Despite this, consumers tend to believe that potatoes are high in calories and in fat compared with other carbohydrate sources such as rice or pasta, an incorrect assumption since a potato has negligible fat and a low energy density similar to legumes. Data from short-term nutrition intervention trials, suggest that potatoes consumed as part of a low-glycemic load meal can play a role in the prevention or treatment of MetS. However, the impact of long-term potato consumption on cardiometabolic risk factors associated with MetS is not known. Therefore, there is a critical need to determine if regular (> 4 times per week) potato consumption can improve cardiometabolic health in individuals with MetS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resides in Northwest Arkansas
  • Age 18+ years
  • Metabolic Syndrome (characterized by participant having three or more of the following measurements: abdominal obesity, triglyceride level over 150 mg/dl, HDL cholesterol < 40 mg/dl in men and 50 mg/dl in women, systolic blood pressure of 130 mm Hg or diastolic blood pressure of 85 mm Hg, and/or fasting glucose > 100 mg/dL)
  • All ethnicities
  • Female and male
  • Currently consuming a high glycemic load diet

Exclusion criteria

  • Food allergies
  • Dietary restrictions (e.g. vegetarian, vegan, etc.)
  • Trying to lose weight in last 3 months
  • Prescription medications related to heart disease or type 2 diabetes
  • Fear of needles

Treatment and study plan

Higher protein, low glycemic load diet

Dietary Supplement

All dietary treatments will be designed to be isoenergetic within individual participants. Energy content of the diets will be individualized to ensure weight maintenance throughout the dietary intervention period using the Harris Benedict equation x 1.35. Glycemic load for the treatment groups will be calculated using the following equation:

Glycemic Load = Glycemic Index x Grams of carbohydrates/100. Potatoes, processed potato products, and control carbohydrate foods will be provided.

Primary outcomes

  1. Serum lipid levels

    Time frame: Change from baseline at 16 weeks

    Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides

  2. Plasma glucose levels

    Time frame: Change from baseline at 16 weeks

    Plasma glucose levels

Secondary outcomes

  1. Waist circumference

    Time frame: Change from baseline at 16 weeks

    Waist circumference in centimeters

  2. Dietary intake

    Time frame: Change of time of study (16 weeks)

    Monthly food records will be recorded to determine changes in diet intake

  3. Mood

    Time frame: Change from baseline at 16 weeks

    Mood will be measured using the Profile of Mood States questionnaire

  4. Sleep quality and duration

    Time frame: Change from baseline at 16 weeks

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index

  5. Sleep duration

    Time frame: Change from baseline at 16 weeks

    Sleep duration will be assessed using an Actigraph sleep monitor

  6. Marker of appetite and sleep

    Time frame: Change from baseline at 16 weeks

    Orexin (also known as hypocretin)

  7. Appetite

    Time frame: Change from baseline at 16 weeks

    Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

The Effect of a Higher Protein, Lower Glycemic Load Diet Containing Potato or Potato-based Products on Metabolic Health in Adults With Metabolic Syndrome

Acronym: MAPS

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
May 2, 2019
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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