NCT03310476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

September 21, 2017

Last Update Submit

September 12, 2019

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in postprandial glucose and insulin concentrations

    Postprandial glucose and insulin concentrations will be compared between interventions

    Change in glucose and insulin concentrations collected 15, 30, 60, and 120 minutes following potato intake

Secondary Outcomes (3)

  • Change in postprandial glucagon-like peptide- 1 (GLP-1, pg/mL) concentrations

    Change in GLP-1 concentrations collected 15, 30, 60, and 120 minutes following potato intake

  • Change in postprandial peptide YY (PYY, pg/mL) concentrations

    Change in PYY concentrations collected 15, 30, 60, and 120 minutes following potato intake

  • Change in postprandial glucose-dependent insulinotropic peptide (GIP, pg/mL) concentrations

    Change in GIP concentrations collected 15, 30, 60, and 120 minutes folllowing potato intake

Other Outcomes (2)

  • Change in postprandial subjective satiety

    VAS measured immediately and 120 minutes following potato intake

  • Change in subsequent energy intake

    Subsequent energy intake over 48 hours following potato intake

Study Arms (2)

Baked, consumed chilled potatoes

EXPERIMENTAL
Other: Potatoes

Boiled, consumed hot potatoes

EXPERIMENTAL
Other: Potatoes

Interventions

PotatoesOTHER

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.

Baked, consumed chilled potatoesBoiled, consumed hot potatoes

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight and obese (BMI between 28 and 40 kg/m\^2)
  • Any race or ethnicity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mindy Patterson, PhD, RDN

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 16, 2017

Study Start

January 1, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)