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Diet and Health in Adults With Metabolic Syndrome (MAPS)

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Higher protein, low glycemic load diet
Sponsored by
University of Arkansas, Fayetteville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ArkansasRecruiting
  • University of ArkansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Higher Protein, Low Glycemic Load with Potatoes

Higher Protein, Low Glycemic Load with Processed Potatoes

Higher Protein, Low Glycemic Load - Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Serum lipid levels
Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
Plasma glucose levels
Plasma glucose levels

Secondary Outcome Measures

Waist circumference
Waist circumference in centimeters
Dietary intake
Monthly food records will be recorded to determine changes in diet intake
Mood
Mood will be measured using the Profile of Mood States questionnaire
Sleep quality and duration
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
Sleep duration
Sleep duration will be assessed using an Actigraph sleep monitor
Marker of appetite and sleep
Orexin (also known as hypocretin)
Appetite
Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)

Full Information

First Posted
April 26, 2019
Last Updated
June 16, 2021
Sponsor
University of Arkansas, Fayetteville
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1. Study Identification

Unique Protocol Identification Number
NCT03935048
Brief Title
Diet and Health in Adults With Metabolic Syndrome
Acronym
MAPS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Higher Protein, Low Glycemic Load with Potatoes
Arm Type
Experimental
Arm Description
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.
Arm Title
Higher Protein, Low Glycemic Load with Processed Potatoes
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Higher Protein, Low Glycemic Load - Control
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Higher protein, low glycemic load diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum lipid levels
Description
Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
Time Frame
Change from baseline at 16 weeks
Title
Plasma glucose levels
Description
Plasma glucose levels
Time Frame
Change from baseline at 16 weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Waist circumference in centimeters
Time Frame
Change from baseline at 16 weeks
Title
Dietary intake
Description
Monthly food records will be recorded to determine changes in diet intake
Time Frame
Change of time of study (16 weeks)
Title
Mood
Description
Mood will be measured using the Profile of Mood States questionnaire
Time Frame
Change from baseline at 16 weeks
Title
Sleep quality and duration
Description
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
Time Frame
Change from baseline at 16 weeks
Title
Sleep duration
Description
Sleep duration will be assessed using an Actigraph sleep monitor
Time Frame
Change from baseline at 16 weeks
Title
Marker of appetite and sleep
Description
Orexin (also known as hypocretin)
Time Frame
Change from baseline at 16 weeks
Title
Appetite
Description
Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)
Time Frame
Change from baseline at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD
Phone
479-575-4474
Email
baum@uark.edu
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD
Phone
479-575-4474
Email
baum@uark.edu
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Diet and Health in Adults With Metabolic Syndrome

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