Diet and Health in Adults With Metabolic Syndrome

NCT03935048 | Active Not Recruiting

• 1 other identifier: 1901172168
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Serum lipid levels

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

  Change from baseline at 16 weeks

• Plasma glucose levels

  Plasma glucose levels

  Change from baseline at 16 weeks

Secondary Outcomes (7)

• Waist circumference

  Change from baseline at 16 weeks

• Dietary intake

  Change of time of study (16 weeks)

• Mood

  Change from baseline at 16 weeks

• Sleep quality and duration

  Change from baseline at 16 weeks

• Sleep duration

  Change from baseline at 16 weeks

Study Arms (3)

Higher Protein, Low Glycemic Load with Potatoes

EXPERIMENTAL

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.

Dietary Supplement: Higher protein, low glycemic load diet

Higher Protein, Low Glycemic Load with Processed Potatoes

ACTIVE COMPARATOR

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.

Dietary Supplement: Higher protein, low glycemic load diet

Higher Protein, Low Glycemic Load - Control

PLACEBO COMPARATOR

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.

Dietary Supplement: Higher protein, low glycemic load diet

Interventions

Higher protein, low glycemic load diet 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 with Potatoes; Higher Protein, Low Glycemic Load with Processed Potatoes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)