Postprandial Effect of Carbohydrate Beverage ConsumptionNCT02211599
Fat Burning After a Meal
A study testing 15% protein, 30% protein and Sweetened beverage in people with Postprandial Effect of Carbohydrate Beverage Consumption, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Effect of Carbohydrate Beverage Consumption
- What is being tested?
- 15% protein, 30% protein and Sweetened beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI less than 25 kg/m2
- ability to sign the consent form
- availability of transportation
Who cannot join
- percent body fat greater than or equal to 25% for males and 35% for females
- allergies to any study foods
- more than a 10% change in body weight within the past 2 months
- current or planned pregnancy
- lactation
- metabolic illness/disease(s)
Show all 12Show fewer
- active cancer or in short-term remission (less than 3 years)
- infectious diseases
- alcohol or drug abuse
- tobacco use
- presence of acute illness
- taking medications known to affect energy expenditure and appetite
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Post-Prandial Substrate Utilization in Response to the Inclusion of Sweetened Beverage to Meals With Different Levels of Protein Content
The purpose of the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins.
- Being tested
- 15% protein, 30% protein, Sweetened beverage
- Keywords
- protein, carbohydrate, lipid, oxidation, fat, sugar, juice, obesity
- Medical subject headings
- Platelet Glycoprotein IV Deficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% proteinOther
Meal to provide 15%en from protein.
30% proteinOther
Meal to provide 30%en from protein.
Sweetened beverageOther
Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).
| Study group | Role | What they receive |
|---|---|---|
| 15% protein meal and sweetened beverage | Experimental | Breakfast and lunch will each contain 15% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized. Receives: Other: 15% protein; Other: Sweetened beverage |
| 30% protein meal and sweetened beverage | Experimental | Breakfast and lunch will each contain 30% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized. Receives: Other: 30% protein; Other: Sweetened beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial lipid oxidation rate
Measured: 4 hours after meal consumption
Secondary outcomes (3)
Energy expenditure measured by postprandial thermogenesis
Measured: 4 hours after meal consumption
Postprandial protein oxidation
Measured: 4 hours after meal consumption
Postprandial carbohydrate oxidation
Measured: 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2016
- Study completionJun 2016
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 Postprandial Effect of Carbohydrate Beverage ConsumptionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research CenterJames Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211599
- Sponsor's protocol ID
- GFHNRC507
- Status last verified
- Jan 2022
- First submitted
- 5 Aug 2014
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Casperson SL, Hall C, Roemmich JN. Postprandial energy metabolism and substrate oxidation in response to the inclusion of a sugar- or non-nutritive sweetened beverage with meals differing in protein content. BMC Nutr. 2017 Jul 21;3:49. doi: 10.1186/s40795-017-0170-2. eCollection 2017.
PubMed 32153829
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Prandial Substrate Utilization in Response to the Inclusion of Sweetened Beverage to Meals With Different Levels of Protein Content
- ClinicalTrials.gov ID
- NCT02211599
- Acronym / sponsor ID
- GFHNRC507
- Keywords
- protein, carbohydrate, lipid, oxidation, fat, sugar, juice, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Nov 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Aug 2014 (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 the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15% protein meal and sweetened beverage | Experimental | Other: 15% protein, Other: Sweetened beverageBreakfast and lunch will each contain 15% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized. |
| 30% protein meal and sweetened beverage | Experimental | Other: 30% protein, Other: Sweetened beverageBreakfast and lunch will each contain 30% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI less than 25 kg/m2
- ability to sign the consent form
- availability of transportation
Key exclusion criteria (12 listed)
- percent body fat greater than or equal to 25% for males and 35% for females
- allergies to any study foods
- more than a 10% change in body weight within the past 2 months
- current or planned pregnancy
- lactation
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 |
|---|---|---|
| 15% proteinMeal to provide 15%en from protein. | Other | 15% protein meal and sweetened beverage |
| 30% proteinMeal to provide 30%en from protein. | Other | 30% protein meal and sweetened beverage |
| Sweetened beverageBeverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener). | Other | 15% protein meal and sweetened beverage, 30% protein meal and sweetened beverage |
Primary outcome
Postprandial lipid oxidation rate
Time frame: 4 hours after meal consumption
3 secondary outcomes
Energy expenditure measured by postprandial thermogenesis
Time frame: 4 hours after meal consumption
Postprandial protein oxidation
Time frame: 4 hours after meal consumption
Postprandial carbohydrate oxidation
Time frame: 4 hours after meal consumption
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 2 Feb 2022.
- Derived from this study: PubMed 32153829Casperson SL, Hall C, Roemmich JN. Postprandial energy metabolism and substrate oxidation in response to the inclusion of a sugar- or non-nutritive sweetened beverage with meals differing in protein content. BMC Nutr. 2017 Jul 21;3:49. doi: 10.1186/s40795-017-0170-2. eCollection 2017.
- Individual participant dataSharing planned: No
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.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% protein, 30% protein and Sweetened beverage in people with Postprandial Effect of Carbohydrate Beverage Consumption, 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 3 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 2 Feb 2022. 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?
Postprandial lipid oxidation rate (time frame: 4 hours after meal consumption). 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 NCT02211599, 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 2 Feb 2022.