Diet and Health in Adults With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MAPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935048
• Other study ID #: 1901172168
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2021
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Higher protein, low glycemic load diet
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.

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipid levels	Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides	Change from baseline at 16 weeks
Primary	Plasma glucose levels	Plasma glucose levels	Change from baseline at 16 weeks
Secondary	Waist circumference	Waist circumference in centimeters	Change from baseline at 16 weeks
Secondary	Dietary intake	Monthly food records will be recorded to determine changes in diet intake	Change of time of study (16 weeks)
Secondary	Mood	Mood will be measured using the Profile of Mood States questionnaire	Change from baseline at 16 weeks
Secondary	Sleep quality and duration	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index	Change from baseline at 16 weeks
Secondary	Sleep duration	Sleep duration will be assessed using an Actigraph sleep monitor	Change from baseline at 16 weeks
Secondary	Marker of appetite and sleep	Orexin (also known as hypocretin)	Change from baseline at 16 weeks
Secondary	Appetite	Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)	Change from baseline at 16 weeks