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Diet and Health in Adults With Metabolic Syndrome

  • Clinicaltrials.gov identifier

    NCT03935048

  • Recruitment Status

    Recruiting

  • First Posted

    May 2, 2019

  • Last update posted

    January 28, 2020

Study Description

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.

  • Condition or Disease:Metabolic Syndrome
  • Intervention/Treatment: Dietary Supplement: Higher protein, low glycemic load diet
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Basic Science
  • Official Title: The Effect of a Higher Protein, Lower Glycemic Load Diet Containing Potato or Potato-based Products on Metabolic Health in Adults With Metabolic Syndrome
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: May 2021

Arms and interventions

Arm Intervention/treatment
Placebo Comparator: 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.
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.
Experimental: 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.
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.
Active Comparator: 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.
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.

Outcome Measures

  • Primary Outcome Measures: 1. Serum lipid levels [ Time Frame: Change from baseline at 16 weeks ]
    Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
  • 2. Plasma glucose levels [ Time Frame: Change from baseline at 16 weeks ]
    Plasma glucose levels
  • Secondary Outcome Measures: 1. Dietary intake [ Time Frame: Change of time of study (16 weeks) ]
    Monthly food records will be recorded to determine changes in diet intake
  • 2. Mood [ Time Frame: Change from baseline at 16 weeks ]
    Mood will be measured using the Profile of Mood States questionnaire
  • 3. Waist circumference [ Time Frame: Change from baseline at 16 weeks ]
    Waist circumference in centimeters
  • 4. Sleep quality and duration [ Time Frame: Change from baseline at 16 weeks ]
    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
  • 5. Sleep duration [ Time Frame: Change from baseline at 16 weeks ]
    Sleep duration will be assessed using an Actigraph sleep monitor
  • 6. Marker of appetite and sleep [ Time Frame: Change from baseline at 16 weeks ]
    Orexin (also known as hypocretin)
  • 7. Appetite [ Time Frame: Change from baseline at 16 weeks ]
    Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)

Eligibility Criteria

  • Ages Eligible for Study: 18 to 85 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Contacts

Locations

United States, Arkansas
University of Arkansas
Fayetteville

United States, Arkansas
University of Arkansas
Fayetteville

Sponsors and Collaborators

University of Arkansas, Fayetteville

More Information

  • Responsible Party: University of Arkansas, Fayetteville
  • ClinicalTrials.gov Identifier: NCT03935048 History of Changes
  • Other Study ID Numbers: 1901172168
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: January 28, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Metabolic Syndrome Syndrome