- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935048
Diet and Health in Adults With Metabolic Syndrome (MAPS)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
- University of Arkansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum lipid levels
Time Frame: Change from baseline at 16 weeks
|
Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides
|
Change from baseline at 16 weeks
|
|
Plasma glucose levels
Time Frame: Change from baseline at 16 weeks
|
Plasma glucose levels
|
Change from baseline at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference
Time Frame: Change from baseline at 16 weeks
|
Waist circumference in centimeters
|
Change from baseline at 16 weeks
|
|
Dietary intake
Time Frame: Change of time of study (16 weeks)
|
Monthly food records will be recorded to determine changes in diet intake
|
Change of time of study (16 weeks)
|
|
Mood
Time Frame: Change from baseline at 16 weeks
|
Mood will be measured using the Profile of Mood States questionnaire
|
Change from baseline at 16 weeks
|
|
Sleep quality and duration
Time Frame: Change from baseline at 16 weeks
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
|
Change from baseline at 16 weeks
|
|
Sleep duration
Time Frame: Change from baseline at 16 weeks
|
Sleep duration will be assessed using an Actigraph sleep monitor
|
Change from baseline at 16 weeks
|
|
Marker of appetite and sleep
Time Frame: Change from baseline at 16 weeks
|
Orexin (also known as hypocretin)
|
Change from baseline at 16 weeks
|
|
Appetite
Time Frame: Change from baseline at 16 weeks
|
Anorexigenic appetite hormone - PYY (peptide tyrosine tyrosine)
|
Change from baseline at 16 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1901172168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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