Diet and Health in Adults With Metabolic Syndrome

NCT ID: NCT03935048

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2025-12-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Higher Protein, Low Glycemic Load with Potatoes

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.

Group Type: EXPERIMENTAL

Higher protein, low glycemic load diet

Intervention Type: 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.

Higher Protein, Low Glycemic Load with Processed Potatoes

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.

Group Type: ACTIVE_COMPARATOR

Higher protein, low glycemic load diet

Intervention Type: 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.

Higher Protein, Low Glycemic Load - Control

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.

Group Type: PLACEBO_COMPARATOR

Higher protein, low glycemic load diet

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas, Fayetteville

OTHER

Sponsor Role: lead

Responsible Party

Jamie Baum

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Arkansas

Fayetteville, Arkansas, United States

Countries

United States

Other Identifiers

1901172168

Identifier Type: -

Identifier Source: org_study_id