An interventional study of Higher protein, low glycemic load diet in Metabolic Syndrome, sponsored by University of Arkansas, Fayetteville. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by University of Arkansas, Fayetteville · Not applicable, Interventional, and Basic science
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Arkansas, Fayetteville is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 (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 (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
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.
Serum lipid levels
Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
Time frame: Change from baseline at 16 weeks
Plasma glucose levels
Plasma glucose levels
Time frame: Change from baseline at 16 weeks
Waist circumference
Waist circumference in centimeters
Time frame: Change from baseline at 16 weeks
Dietary intake
Monthly food records will be recorded to determine changes in diet intake
Time frame: Change of time of study (16 weeks)
Mood
Mood will be measured using the Profile of Mood States questionnaire
Time frame: Change from baseline at 16 weeks
Sleep quality and duration
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
Time frame: Change from baseline at 16 weeks
Sleep duration
Sleep duration will be assessed using an Actigraph sleep monitor
Time frame: Change from baseline at 16 weeks
Marker of appetite and sleep
Orexin (also known as hypocretin)
Time frame: Change from baseline at 16 weeks
Appetite
Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)
Time frame: Change from baseline at 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Arkansas, Fayetteville