Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potatoes
Sponsored by
About this trial
This is an interventional prevention trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Overweight and obese (BMI between 28 and 40 kg/m^2)
- Any race or ethnicity
Exclusion Criteria:
- Diabetes or other metabolic disorder, cancer, or cardiovascular disease
- Smoking
- Pregnant or lactating
- More than 5% weight loss or gain over prior 6 months
- Following a special diet
- Sensitivity or aversion to potatoes
Sites / Locations
- Texas Woman's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Baked, consumed chilled potatoes
Boiled, consumed hot potatoes
Arm Description
Outcomes
Primary Outcome Measures
Change in postprandial glucose and insulin concentrations
Postprandial glucose and insulin concentrations will be compared between interventions
Secondary Outcome Measures
Change in postprandial glucagon-like peptide- 1 (GLP-1, pg/mL) concentrations
Postprandial changes in GLP-1 will be compared between interventions
Change in postprandial peptide YY (PYY, pg/mL) concentrations
Postprandial changes in PYY will be compared between interventions
Change in postprandial glucose-dependent insulinotropic peptide (GIP, pg/mL) concentrations
Postprandial changes in GIP will be compared between interventions
Full Information
NCT ID
NCT03310476
First Posted
September 21, 2017
Last Updated
September 12, 2019
Sponsor
Texas Woman's University
Collaborators
Alliance for Potato Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT03310476
Brief Title
Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females
Official Title
Influence of Resistant Starch in Baked and Boiled Potatoes on Glycemic and Satiety Responses in Overweight Females
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Alliance for Potato Research and Education
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
Resistant starch (RS) is a type of fiber that has unique digestive properties that can impact overall health including glucose homeostasis and satiety. RS found in potatoes can be increased by using certain cooking methods and serving temperatures. The purpose of this trial will compare the acute glycemic and satiety responses after consuming potatoes differing in RS content that are 1) baked then chilled or 2) boiled and consumed hot in overweight females on two separate occasions.
Detailed Description
Potatoes are a low-cost, nutrient-dense dietary staple in the U.S. rich in complex carbohydrates, potassium, magnesium, and fiber, but low in fat and sodium. Starch is the main complex carbohydrate found in potatoes that yields glucose to contribute to overall energy needs. Another type of starch found in potatoes is resistant to amylase hydrolysis in the small intestine which is resistant starch (RS). Trials using RS as a functional ingredient (~15-30 g/day) in healthy and overweight adults resulted in improvements in postprandial glucose, insulin sensitivity, satiety hormone response, and subjective satiety. Limited data exists using RS naturally found in commonly consumed foods, such as potatoes. Altering the cooking methods and serving temperatures of potatoes can influence the amount of RS to impact glucose, satiety hormone response, and subjective satiety. Using a cross-sectional, cross-over design, the aim of this study will determine how potatoes 1) baked and chilled or 2) boiled and consumed hot influence postprandial glycemic parameters, satiety hormones (glucagon-like peptide-1, peptide YY, and glucose-dependent insulinotropic polypeptide), subjective satiety, and subsequent energy intake in overweight females.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baked, consumed chilled potatoes
Arm Type
Experimental
Arm Title
Boiled, consumed hot potatoes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Potatoes
Intervention Description
Participants will follow the same protocol for each arm with a minimum of 1-week wash-out period between arms. For each arm, fasting blood will be collected then 200 g of potato will be consumed. Postprandial blood will be collected 15, 30, 60, and 120 minutes. Subjective satiety will be assessed using Visual Analogue Scale three times, as well as 48-hour subsequent dietary intake.
Primary Outcome Measure Information:
Title
Change in postprandial glucose and insulin concentrations
Description
Postprandial glucose and insulin concentrations will be compared between interventions
Time Frame
Change in glucose and insulin concentrations collected 15, 30, 60, and 120 minutes following potato intake
Secondary Outcome Measure Information:
Title
Change in postprandial glucagon-like peptide- 1 (GLP-1, pg/mL) concentrations
Description
Postprandial changes in GLP-1 will be compared between interventions
Time Frame
Change in GLP-1 concentrations collected 15, 30, 60, and 120 minutes following potato intake
Title
Change in postprandial peptide YY (PYY, pg/mL) concentrations
Description
Postprandial changes in PYY will be compared between interventions
Time Frame
Change in PYY concentrations collected 15, 30, 60, and 120 minutes following potato intake
Title
Change in postprandial glucose-dependent insulinotropic peptide (GIP, pg/mL) concentrations
Description
Postprandial changes in GIP will be compared between interventions
Time Frame
Change in GIP concentrations collected 15, 30, 60, and 120 minutes folllowing potato intake
Other Pre-specified Outcome Measures:
Title
Change in postprandial subjective satiety
Description
Change in postprandial subjective satiety measured by Visual Analogue Scale (VAS) will be compared between interventions
Time Frame
VAS measured immediately and 120 minutes following potato intake
Title
Change in subsequent energy intake
Description
Change in subsequent energy intake 48 hours following potato intake will be compared between interventions
Time Frame
Subsequent energy intake over 48 hours following potato intake
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight and obese (BMI between 28 and 40 kg/m^2)
Any race or ethnicity
Exclusion Criteria:
Diabetes or other metabolic disorder, cancer, or cardiovascular disease
Smoking
Pregnant or lactating
More than 5% weight loss or gain over prior 6 months
Following a special diet
Sensitivity or aversion to potatoes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mindy Patterson, PhD, RDN
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females
We'll reach out to this number within 24 hrs