High-Protein, Low-Glycemic Diet for Metabolic Syndrome

(MAPS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Heart disease, Diabetes medications

Disqualifiers: Food allergies, Dietary restrictions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial excludes participants who are on prescription medications related to heart disease or type 2 diabetes, so you may need to stop these medications to participate.

What data supports the effectiveness of the treatment Higher protein, low glycemic load diet for Metabolic Syndrome?

Research suggests that diets with a low glycemic load (which measures how much a food raises blood sugar levels) and higher protein content can help manage weight and reduce the risk of developing metabolic syndrome, a condition that increases the risk of heart disease and diabetes. ^{1 2 3 4 5}

Is a high-protein, low-glycemic diet safe for humans?

High-protein diets have been shown to help with weight loss and improve heart health by lowering blood pressure and improving cholesterol levels. However, they may increase the risk of diabetes and cancer if red meat intake is high. Overall, these diets are generally considered safe for weight management and improving metabolic health, but it's important to balance protein sources and consult with a healthcare provider. ^{5 6 7 8 9}

How does the high-protein, low-glycemic diet treatment differ from other treatments for metabolic syndrome?

This treatment is unique because it combines a high-protein diet with a low-glycemic load, which may help manage metabolic syndrome by potentially improving blood sugar levels and reducing the risk of chronic diseases like type 2 diabetes. Unlike other diets, it focuses on both protein intake and the glycemic impact of foods, which could offer more balanced metabolic benefits. ^{1 5 10 11 12}

Eligibility Criteria

Adults over 18 with Metabolic Syndrome, characterized by a combination of high triglycerides, low HDL cholesterol, high blood pressure, elevated fasting glucose levels or abdominal obesity. Participants should be from Northwest Arkansas and currently eating a diet high in glycemic load. Those on heart disease or diabetes medications, with needle phobia, food allergies or dietary restrictions like vegetarianism are excluded.

Inclusion Criteria

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)

People of all races and ethnicities are eligible.

I am either female or male.

Exclusion Criteria

You have specific dietary preferences or restrictions, such as being a vegetarian or vegan.

You have been actively trying to lose weight in the past 3 months.

You are afraid of needles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume low- to moderate-glycemic load meals for 16 weeks, with specific dietary interventions based on trial arm

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Higher protein, low glycemic load diet

Trial Overview The trial is testing the effects of a higher protein, low glycemic load diet that includes potatoes more than four times per week on individuals with Metabolic Syndrome to see if it improves their cardiometabolic health.

Participant Groups

Group I: Higher Protein, Low Glycemic Load with Potatoes Experimental Treatment 1 Intervention

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 II: Higher Protein, Low Glycemic Load with Processed Potatoes Active Control 1 Intervention

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 III: Higher Protein, Low Glycemic Load - Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Findings from Research

A study of 179 older adults found that those following a lower-glycemic-load diet had significantly lower glycemic loads compared to those on a higher-glycemic-load diet, suggesting dietary patterns can influence metabolic health.

Participants in the lower-glycemic-load group consumed more nutrient-dense carbohydrates like whole grains, fruits, and vegetables, indicating that promoting these foods could help reduce the risk of obesity and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. Davis, MS., Miller, CK., Mitchell, DC.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Plasma lipidomic profiles after a low and high glycemic load dietary pattern in a randomized controlled crossover feeding study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of a reduced-glycemic-load diet on body weight, body composition, and cardiovascular disease risk markers in overweight and obese adults. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Dietary protein and the glycemic index handle insulin resistance within a nutritional program for avoiding weight regain after energy-restricted induced weight loss. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of glycemic load on metabolic risk markers in subjects at increased risk of developing metabolic syndrome. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of high protein and high fiber weight-loss diets in women with risk factors for the metabolic syndrome: a randomized trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Dietary glycemic index, dietary glycemic load and mortality among men with established cardiovascular disease. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The role of high-protein diets in body weight management and health. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

DASH-like diets high in protein or monounsaturated fats improve metabolic syndrome and calculated vascular risk. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Protein in optimal health: heart disease and type 2 diabetes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The metabolic syndrome in relation with the glycemic index and the glycemic load. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Low glycemic load diets protect against metabolic syndrome and Type 2 diabetes mellitus in the male Nile rat. [2018]