Clinical trial NCT03935048: Diet and Health in Adults with Metabolic Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum lipid levels
timeFrame: Change from baseline at 16 weeks
measure: Plasma glucose levels
timeFrame: Change from baseline at 16 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline at 16 weeks
measure: Dietary intake
timeFrame: Change of time of study (16 weeks)
measure: Mood
timeFrame: Change from baseline at 16 weeks
measure: Sleep quality and duration
timeFrame: Change from baseline at 16 weeks
measure: Sleep duration
timeFrame: Change from baseline at 16 weeks
measure: Marker of appetite and sleep
timeFrame: Change from baseline at 16 weeks
measure: Appetite
timeFrame: Change from baseline at 16 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
References: