ObesityNCT01771926
Lifestyle Modification and Potato Consumption
A study testing potatoes and other carbohydrate in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- potatoes and other carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2016
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 20-65 years of age.
- Overweight or obese (BMI 25 - 39.9 Kg/m2)
- Impaired Glucose Tolerance: fasting glucose between 100-125 mg/dL
- Willingness to comply with the demands of the experimental protocol
- Sedentary lifestyle
Who cannot join
- Major medical condition
- Smokers
- Unable to perform moderate exercise
- Use of medications that alter glucose or lipid metabolism
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.
Read the detailed description
Our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.
- Conditions
- Obesity
- Being tested
- potatoes, other carbohydrate
- Keywords
- resistant starch, lifestyle intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potatoesOther
Daily intake of assigned treatment for 8 weeks
other carbohydrateOther
Daily intake of assigned treatment for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Resistant Starch Potatoes | Experimental | Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. Receives: Other: potatoes |
| Low Resistant Starch Potatoes | Experimental | Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. Receives: Other: potatoes |
| Other Carbohydrate Source | Placebo comparator | Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. Receives: Other: other carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
Measured: Days 0, 14, 28, 42, 56
Secondary outcomes (2)
Weight Loss
Measured: Days 0, 14, 28, 42, 56
Functional Fitness
Measured: Days 0 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan K Raatz, PhD, MPH, RD, Principal investigator, USDA GFHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771926
- Sponsor's protocol ID
- GFHNRC024
- Status last verified
- Aug 2018
- First submitted
- 29 Mar 2012
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification and Potato Consumption
- ClinicalTrials.gov ID
- NCT01771926
- Acronym / sponsor ID
- GFHNRC024
- Conditions
- Obesity
- Keywords
- resistant starch, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Jan 2013 (estimated)
- 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.
The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.
Detailed description
Our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Resistant Starch Potatoes | Experimental | Other: potatoesSubjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. |
| Low Resistant Starch Potatoes | Experimental | Other: potatoesSubjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. |
| Other Carbohydrate Source | Placebo comparator | Other: other carbohydrateSubjects will receive 1 serving daily for 8 weeks during the weight loss group sessions. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 20-65 years of age.
- Overweight or obese (BMI 25 - 39.9 Kg/m2)
- Impaired Glucose Tolerance: fasting glucose between 100-125 mg/dL
- Willingness to comply with the demands of the experimental protocol
- Sedentary lifestyle
Key exclusion criteria (5 listed)
- Major medical condition
- Smokers
- Unable to perform moderate exercise
- Use of medications that alter glucose or lipid metabolism
- Pregnant or lactating
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 |
|---|---|---|
| potatoesDaily intake of assigned treatment for 8 weeks | Other | High Resistant Starch Potatoes, Low Resistant Starch Potatoes |
| other carbohydrateDaily intake of assigned treatment for 8 weeks | Other | Other Carbohydrate Source |
Primary outcome
Glucose Tolerance
Time frame: Days 0, 14, 28, 42, 56
2 secondary outcomes
Weight Loss
Time frame: Days 0, 14, 28, 42, 56
Functional Fitness
Time frame: Days 0 and 57
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 3 Aug 2018.
- Grand Forks Human Nutrition Research CenterLink provided by the sponsor.
- 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.
Susan K Raatz, PhD, MPH, RD principal investigator
USDA GFHNRC
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 and other carbohydrate in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center 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 5 inclusion and 5 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 3 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Glucose Tolerance (time frame: Days 0, 14, 28, 42, 56). 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 3 Aug 2018.