Overweight and ObesityNCT03310476
Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females
A study testing Potatoes in people with Overweight and Obesity, run by Texas Woman's University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Potatoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight and obese (BMI between 28 and 40 kg/m^2)
- Any race or ethnicity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Resistant Starch in Baked and Boiled Potatoes on Glycemic and Satiety Responses in Overweight Females
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Potatoes
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Baked, consumed chilled potatoes | Experimental | Not described Receives: Other: Potatoes |
| Boiled, consumed hot potatoes | Experimental | Not described Receives: Other: Potatoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glucose and insulin concentrations
Postprandial glucose and insulin concentrations will be compared between interventions
Measured: 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
Postprandial changes in GLP-1 will be compared between interventions
Measured: Change in GLP-1 concentrations collected 15, 30, 60, and 120 minutes following potato intake
Change in postprandial peptide YY (PYY, pg/mL) concentrations
Postprandial changes in PYY will be compared between interventions
Measured: 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
Postprandial changes in GIP will be compared between interventions
Measured: Change in GIP concentrations collected 15, 30, 60, and 120 minutes folllowing potato intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Jan 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, Mindy Patterson Maziarz, Texas Woman's University
- Investigators
- Mindy Patterson, PhD, RDN, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310476
- Sponsor's protocol ID
- Resistant starch in potatoes
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Resistant Starch in Baked and Boiled Potatoes on Glycemic and Satiety Responses in Overweight Females
- ClinicalTrials.gov ID
- NCT03310476
- Acronym / sponsor ID
- Resistant starch in potatoes
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baked, consumed chilled potatoes | Experimental | Other: Potatoes |
| Boiled, consumed hot potatoes | Experimental | Other: Potatoes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight and obese (BMI between 28 and 40 kg/m^2)
- Any race or ethnicity
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PotatoesParticipants 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. | Other | Baked, consumed chilled potatoes, Boiled, consumed hot potatoes |
Primary outcome
Change in postprandial glucose and insulin concentrations
Time frame: Change in glucose and insulin concentrations collected 15, 30, 60, and 120 minutes following potato intake
Postprandial glucose and insulin concentrations will be compared between interventions
3 secondary outcomes
Change in postprandial glucagon-like peptide- 1 (GLP-1, pg/mL) concentrations
Time frame: Change in GLP-1 concentrations collected 15, 30, 60, and 120 minutes following potato intake
Change in postprandial peptide YY (PYY, pg/mL) concentrations
Time frame: 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
Time frame: Change in GIP concentrations collected 15, 30, 60, and 120 minutes folllowing potato intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mindy Patterson, PhD, RDN principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potatoes in people with Overweight and Obesity, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial glucose and insulin concentrations (time frame: Change in glucose and insulin concentrations collected 15, 30, 60, and 120 minutes following potato intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.