ObesityBBFUSPBNCT01186393
STUDY: Effects of Potatoes in a Weight Loss Program
A study testing Low Glycemic Index and High Glycemic Index in people with Obesity, run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low Glycemic Index and High Glycemic Index
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Mar 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- ≥ 18 years of age who have a body mass index (BMI) of 25 to 35 kg/m2 (inclusive).
Who cannot join
- Total cholesterol (TC) not greater than 300 mg/dL,
- Fasting triglyceride not greater than 300 mg/dL ,
- LDL cholesterol (LDL-C) not greater than 180 mg/dL,
- Smokers
- Female subjects who are pregnant or lactating
- Subjects taking any medications that would interfere with outcomes of the study
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- Subjects with unusual dietary habits (eg., pica)
- Subjects who are actively losing weight or trying to lose weight
- Subjects who are addicted to drugs or alcohol or who are < 1 y in recovery program
- Subjects who present with significant psychiatric or neurological disturbances
- Subjects with known allergy or intolerance to potato products
- Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension ( 140/90 mm Hg), chronic lung, renal or liver disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, 95616
VA Hospital, Mather
Mather, California, 95655
About this study
Official title: CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control
The purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight.
Read the detailed description
The study will examine the effect of including potatoes as part of a calorie restricted diet designed to induce weight loss and improve glycemic control in overweight subjects.
This is a randomized, treatment-controlled, 3-arm, parallel study. The 3 arms of the study will include dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Two diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss and the control diet will be prescribed for weight maintenance. The two energy-restricted diets will include further manipulation, such that, one dietary plan will be a high glycemic index (GI) diet and the other a low glycemic index diet.
- Conditions
- Obesity
- Being tested
- Control, Low Glycemic Index, High Glycemic Index
- Keywords
- Weight Loss, Potatoes, Dietary Meetings, Glycemic Control
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Also called No energy reduction
Dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance.
Low Glycemic IndexBehavioural
Also called Low glycemic index reduced energy
Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.
High Glycemic IndexBehavioural
Also called High glycemic index reduced energy
Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Arm includes dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Control diet will be prescribed for weight maintenance. Receives: Behavioral: Control |
| Low Glycemic Index | Experimental | Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods. Receives: Behavioral: Low Glycemic Index |
| High Glycemic Index | Experimental | Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on High Glycemic Index foods. Receives: Behavioral: High Glycemic Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 12 Weeks
Secondary outcomes (3)
Glucose tolerance
Measured: 12 Weeks
Body composition
Measured: 12 weeks
Blood Pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startMay 2007
- Primary completionNov 2010
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, University of California, DavisC. Tissa Kappagoda, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186393
- Sponsor's protocol ID
- 200715352
- Acronym
- BBFUSPB
- Status last verified
- May 2015
- First submitted
- 19 Aug 2010
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Randolph JM, Edirisinghe I, Masoni AM, Kappagoda T, Burton-Freeman B. Potatoes, glycemic index, and weight loss in free-living individuals: practical implications. J Am Coll Nutr. 2014;33(5):375-84. doi: 10.1080/07315724.2013.875441. Epub 2014 Oct 10.
PubMed 25302575
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control
- ClinicalTrials.gov ID
- NCT01186393
- Acronym / sponsor ID
- BBFUSPB / 200715352
- Conditions
- Obesity
- Keywords
- Weight Loss, Potatoes, Dietary Meetings, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Aug 2010 (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 purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight.
Detailed description
The study will examine the effect of including potatoes as part of a calorie restricted diet designed to induce weight loss and improve glycemic control in overweight subjects.
This is a randomized, treatment-controlled, 3-arm, parallel study. The 3 arms of the study will include dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Two diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss and the control diet will be prescribed for weight maintenance. The two energy-restricted diets will include further manipulation, such that, one dietary plan will be a high glycemic index (GI) diet and the other a low glycemic index diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlArm includes dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Control diet will be prescribed for weight maintenance. |
| Low Glycemic Index | Experimental | Behavioral: Low Glycemic IndexDiets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods. |
| High Glycemic Index | Experimental | Behavioral: High Glycemic IndexDiets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on High Glycemic Index foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women
- ≥ 18 years of age who have a body mass index (BMI) of 25 to 35 kg/m2 (inclusive).
Key exclusion criteria (12 listed)
- Total cholesterol (TC) not greater than 300 mg/dL,
- Fasting triglyceride not greater than 300 mg/dL ,
- LDL cholesterol (LDL-C) not greater than 180 mg/dL,
- Smokers
- Female subjects who are 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 |
|---|---|---|
| ControlAlso: No energy reductionDietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance. | Behavioural | Control |
| Low Glycemic IndexAlso: Low glycemic index reduced energyDiets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods. | Behavioural | Low Glycemic Index |
| High Glycemic IndexAlso: High glycemic index reduced energyDiets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods. | Behavioural | High Glycemic Index |
Primary outcome
Weight Loss
Time frame: 12 Weeks
3 secondary outcomes
Glucose tolerance
Time frame: 12 Weeks
Body composition
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
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 18 May 2015.
- Results publication: PubMed 25302575Randolph JM, Edirisinghe I, Masoni AM, Kappagoda T, Burton-Freeman B. Potatoes, glycemic index, and weight loss in free-living individuals: practical implications. J Am Coll Nutr. 2014;33(5):375-84. doi: 10.1080/07315724.2013.875441. Epub 2014 Oct 10.
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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.
Britt Burton-Freeman, Ph.D principal investigator
University of California, Davis
C. Tissa Kappagoda, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Index and High Glycemic Index in people with Obesity, run by University of California, Davis at 2 sites 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 12 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Weight Loss (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186393, which also lists 1 linked publication.
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 18 May 2015.