Diet and Health in Adults With Metabolic Syndrome (MAPS)

University of Arkansas, Fayetteville

Status: Active, not recruiting

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Higher protein, low glycemic load diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03935048

1901172168

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Higher Protein, Low Glycemic Load with Potatoes

Experimental group

Description:

Higher 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.

Treatment:

Dietary Supplement: Higher protein, low glycemic load diet

Higher Protein, Low Glycemic Load with Processed Potatoes

Active Comparator group

Description:

Higher 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.

Treatment:

Dietary Supplement: Higher protein, low glycemic load diet

Higher Protein, Low Glycemic Load - Control

Placebo Comparator group

Description:

Higher 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.

Treatment:

Dietary Supplement: Higher protein, low glycemic load diet