MedPath

Diet and Health in Adults with Metabolic Syndrome

Not Applicable
Active, not recruiting
Conditions
Metabolic Syndrome
Interventions
Dietary Supplement: Higher protein, low glycemic load diet
Registration Number
NCT03935048
Lead Sponsor
University of Arkansas, Fayetteville
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Higher Protein, Low Glycemic Load with PotatoesHigher protein, low glycemic load dietHigher Protein, Low Glycemic Load with Potatoes (HPLG-P): low- to moderate- glycemic load meals containing white potatoes. Participants will consume low- to moderate-glycemic meals for 16 weeks and will need to consume at least 4 meals containing white potatoes.
Higher Protein, Low Glycemic Load - ControlHigher protein, low glycemic load dietHigher Protein, Low Glycemic Load (HPLG-C): low- to moderate- glycemic load meals containing control carbohydrate (e.g. rice, pasta). Participants will consume low- to moderate-glycemic meals for 16 weeks and will need to consume at least 4 meals containing control carbohydrate sources.
Higher Protein, Low Glycemic Load with Processed PotatoesHigher protein, low glycemic load dietHigher Protein, Low Glycemic Load with Processed Potatoes (HPLG-PP): low- to moderate- glycemic load meals containing processed white potato products. Participants will consume low- to moderate-glycemic meals for 16 weeks and will need to consume at least 4 meals containing white potatoes.
Primary Outcome Measures
NameTimeMethod
Plasma glucose levelsChange from baseline at 16 weeks

Plasma glucose levels

Serum lipid levelsChange from baseline at 16 weeks

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

Secondary Outcome Measures
NameTimeMethod
Dietary intakeChange of time of study (16 weeks)

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

MoodChange from baseline at 16 weeks

Mood will be measured using the Profile of Mood States questionnaire

Waist circumferenceChange from baseline at 16 weeks

Waist circumference in centimeters

Sleep durationChange from baseline at 16 weeks

Sleep duration will be assessed using an Actigraph sleep monitor

Sleep quality and durationChange from baseline at 16 weeks

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index

Marker of appetite and sleepChange from baseline at 16 weeks

Orexin (also known as hypocretin)

AppetiteChange from baseline at 16 weeks

Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)

Trial Locations

Locations (1)

University of Arkansas

🇺🇸

Fayetteville, Arkansas, United States

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