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出境医 / 临床实验 / Diet and Health in Adults With Metabolic Syndrome (MAPS)

Diet and Health in Adults With Metabolic Syndrome (MAPS)

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 Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Higher protein, low glycemic load diet Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 30, 2021
Arms and Interventions
Arm Intervention/treatment
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.
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.
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. Waist circumference [ Time Frame: Change from baseline at 16 weeks ]
    Waist circumference in centimeters

  2. Dietary intake [ Time Frame: Change of time of study (16 weeks) ]
    Monthly food records will be recorded to determine changes in diet intake

  3. Mood [ Time Frame: Change from baseline at 16 weeks ]
    Mood will be measured using the Profile of Mood States questionnaire

  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
Layout table for eligibility information
Ages Eligible for Study:   18 Years 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 < 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
Contacts and Locations

Locations
Layout table for location information
United States, Arkansas
University of Arkansas Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Jamie I Baum, PhD    479-575-4474    baum@uark.edu   
University of Arkansas Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Jamie I Baum, PhD    479-575-4474    baum@uark.edu   
Principal Investigator: Jamie I Baum, PhD         
Sponsors and Collaborators
University of Arkansas, Fayetteville
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Serum lipid levels [ Time Frame: Change from baseline at 16 weeks ]
    Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
  • Plasma glucose levels [ Time Frame: Change from baseline at 16 weeks ]
    Plasma glucose levels
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Waist circumference [ Time Frame: Change from baseline at 16 weeks ]
    Waist circumference in centimeters
  • Dietary intake [ Time Frame: Change of time of study (16 weeks) ]
    Monthly food records will be recorded to determine changes in diet intake
  • Mood [ Time Frame: Change from baseline at 16 weeks ]
    Mood will be measured using the Profile of Mood States questionnaire
  • Sleep quality and duration [ Time Frame: Change from baseline at 16 weeks ]
    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
  • Sleep duration [ Time Frame: Change from baseline at 16 weeks ]
    Sleep duration will be assessed using an Actigraph sleep monitor
  • Marker of appetite and sleep [ Time Frame: Change from baseline at 16 weeks ]
    Orexin (also known as hypocretin)
  • Appetite [ Time Frame: Change from baseline at 16 weeks ]
    Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet and Health in Adults With Metabolic Syndrome
Official Title  ICMJE The Effect of a Higher Protein, Lower Glycemic Load Diet Containing Potato or Potato-based Products on Metabolic Health in Adults With Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Higher protein, low glycemic load diet
  • 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.
    Intervention: Dietary Supplement: Higher protein, low glycemic load diet
  • 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.
    Intervention: Dietary Supplement: Higher protein, low glycemic load diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935048
Other Study ID Numbers  ICMJE 1901172168
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jamie Baum, University of Arkansas, Fayetteville
Study Sponsor  ICMJE University of Arkansas, Fayetteville
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Arkansas, Fayetteville
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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