ObesityNCT03518515
Potato Consumption and Energy Balance
A study testing White potato (french fries), White potato (French fries), +seasoning and Almond in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- White potato (french fries), White potato (French fries), +seasoning and Almond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2018to 18 Mar 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18- 50 years old
- Body mass index (BMI) 20- 35
- No dietary restrictions or allergies
- Weight stable
- Access to camera through smartphone, computer or tablet
Who cannot join
- Pregnancy or anticipating pregnancy or lactation
- Nut or food allergy
- Diagnosed diabetes (Type 1 or 2)
- History of weight control surgery (bariatric or liposuction)
- Consumes >1 serving of potatoes daily before enrollment
- Weight loss or gain >5% within past 6 months
- Medical conditions or medications that would prevent the ability to comply with treatment assignment and/or affect energy balance
- Dependence on others for food procurement or preparation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial
A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.
Read the detailed description
This is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato French fry, 3) standard white potato French fry with potential glycemia-modulating spice/seasoning mix added.
Free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. Body composition (via dual energy x-ray absorptiometry; DXA), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.
- Conditions
- Obesity
- Being tested
- White potato (french fries), White potato (French fries), +seasoning, Almond
- Keywords
- nutrition intervention, potato consumption, energy balance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White potato (french fries)Other
If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) each day for 30 days as a part of their usual dietary intake. French fries will be portioned and provided to participants.
White potato (French fries), +seasoningOther
If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) with added potential glycemia modifying seasoning mix each day for 30 days as a part of their usual dietary intake. French fries and seasoning will be portioned and provided to participants.
AlmondOther
If randomized to this group, participants will be asked to consume 1 serving of almonds that is calorically-matched to the French fries (~300 kcal) serving in the other arms each day for 30 days as a part of their usual dietary intake. Almonds will be portioned and provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| White potato (French fries) | Experimental | Participants will be asked to consume 1 serving of French fries each day for 30 days. Receives: Other: White potato (french fries) |
| White potato (French fries), +seasoning | Experimental | Participants will be asked to consume 1 serving of French fries with added seasoning each day for 30 days. Receives: Other: White potato (French fries), +seasoning |
| Almond | Active comparator | Participants will be asked to consume 1 serving of almonds (calorie-matched to other arms) day for 30 days. Receives: Other: Almond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat mass
Determined by dual-energy X-ray absorptiometry.
Measured: baseline and study completion (30 days)
Secondary outcomes (6)
Change in body weight
Measured: baseline and study completion (30 day)
Change in fasting glucose
Measured: baseline and study completion (30 day)
Change in fasting insulin
Measured: baseline and study completion (30 day)
Change in HbA1c
Measured: baseline and study completion (30 day)
Change in caloric Intake
Dietary recall by 3 day food record.
Measured: baseline and study completion (30 days)
Meal Tolerance Test
A subset of subjects from each diet group will participate in a meal-based tolerance test with the study food items.
Measured: Study Completion (30 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start2 Aug 2018
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education, Indiana University
- Responsible party
- Principal investigator, Daniel L. Smith, Jr., University of Alabama at Birmingham
- Investigators
- Daniel Smith, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518515
- Sponsor's protocol ID
- IRB-300001187
- Status last verified
- May 2020
- First submitted
- 24 Apr 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith DL, Hanson RL, Dickinson SL, Chen X, Goss AM, Cleek JB, Garvey WT, Allison DB. French-fried potato consumption and energy balance: a randomized controlled trial. Am J Clin Nutr. 2022 Jun 7;115(6):1626-1636. doi: 10.1093/ajcn/nqac045.
PubMed 35179193
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03518515
- Acronym / sponsor ID
- IRB-300001187
- Conditions
- Obesity
- Keywords
- nutrition intervention, potato consumption, energy balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education, Indiana University
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 8 May 2018 (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.
A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.
Detailed description
This is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato French fry, 3) standard white potato French fry with potential glycemia-modulating spice/seasoning mix added.
Free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. Body composition (via dual energy x-ray absorptiometry; DXA), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White potato (French fries) | Experimental | Other: White potato (french fries)Participants will be asked to consume 1 serving of French fries each day for 30 days. |
| White potato (French fries), +seasoning | Experimental | Other: White potato (French fries), +seasoningParticipants will be asked to consume 1 serving of French fries with added seasoning each day for 30 days. |
| Almond | Active comparator | Other: AlmondParticipants will be asked to consume 1 serving of almonds (calorie-matched to other arms) day for 30 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18- 50 years old
- Body mass index (BMI) 20- 35
- No dietary restrictions or allergies
- Weight stable
- Access to camera through smartphone, computer or tablet
Key exclusion criteria (8 listed)
- Pregnancy or anticipating pregnancy or lactation
- Nut or food allergy
- Diagnosed diabetes (Type 1 or 2)
- History of weight control surgery (bariatric or liposuction)
- Consumes >1 serving of potatoes daily before enrollment
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 |
|---|---|---|
| White potato (french fries)If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) each day for 30 days as a part of their usual dietary intake. French fries will be portioned and provided to participants. | Other | White potato (French fries) |
| White potato (French fries), +seasoningIf randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) with added potential glycemia modifying seasoning mix each day for 30 days as a part of their usual dietary intake. French fries and seasoning will be portioned and provided to participants. | Other | White potato (French fries), +seasoning |
| AlmondIf randomized to this group, participants will be asked to consume 1 serving of almonds that is calorically-matched to the French fries (~300 kcal) serving in the other arms each day for 30 days as a part of their usual dietary intake. Almonds will be portioned and provided to participants. | Other | Almond |
Primary outcome
Change in fat mass
Time frame: baseline and study completion (30 days)
Determined by dual-energy X-ray absorptiometry.
6 secondary outcomes
Change in body weight
Time frame: baseline and study completion (30 day)
Change in fasting glucose
Time frame: baseline and study completion (30 day)
Change in fasting insulin
Time frame: baseline and study completion (30 day)
Change in HbA1c
Time frame: baseline and study completion (30 day)
Change in caloric Intake
Time frame: baseline and study completion (30 days)
Meal Tolerance Test
Time frame: Study Completion (30 day)
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 8 May 2020.
- Derived from this study: PubMed 35179193Smith DL, Hanson RL, Dickinson SL, Chen X, Goss AM, Cleek JB, Garvey WT, Allison DB. French-fried potato consumption and energy balance: a randomized controlled trial. Am J Clin Nutr. 2022 Jun 7;115(6):1626-1636. doi: 10.1093/ajcn/nqac045.
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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.
Daniel Smith, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White potato (french fries), White potato (French fries), +seasoning and Almond in people with Obesity, run by University of Alabama at Birmingham 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 8 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 8 May 2020. 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 fat mass (time frame: baseline and study completion (30 days)). 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 NCT03518515, 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 8 May 2020.