Body WeightLCSNCT02928653
Beverage Consumption and Fine Motor Control
A study testing Beverage in people with Body Weight, run by Purdue University at 1 site in United States.
Trial summary
The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25-40 kg/M2
- Non or rare users of LCS
- Willing to consume large volumes of beverages daily
Who cannot join
- Weight change > 3kg in the last year
- Plan to initiate a new diet plan in the next 6 months
- Exhibit eating restraint
- Pregnant/lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.
- Conditions
- Body Weight
- Being tested
- Beverage
- Keywords
- energy intake, energy expenditure, appetite
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeverageDietary supplement
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sucrose Sweetened Beverage | Active comparator | 100-140 g sucrose/day Receives: Dietary Supplement: Beverage |
| Aspartame Sweetened Beverage | Experimental | 0.541-0.757 g aspartame Sweetened Beverage/day Receives: Dietary Supplement: Beverage |
| Saccharin Sweetened Beverage | Experimental | 0.300-0.455 g saccharin Sweetened Beverage/day Receives: Dietary Supplement: Beverage |
| Sucralose Sweetened Beverage | Experimental | 0.167-0.233 g sucralose Sweetened Beverage/day Receives: Dietary Supplement: Beverage |
| Rebaudioside A Sweeteened Beverage | Experimental | 0.250-0.350 g rebaudioside A Sweetened Beverage/day Receives: Dietary Supplement: Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 12 weeks
Body Composition
Duel emission X-ray absorbtiometry
Measured: 12 weeks
Energy Intake
24 hr Dietary Recall
Measured: 12 weeks
Appetite
24 hr visual analog scale appetite
Measured: 12 weeks
Energy Expenditure
accelerometer
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 posted10 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2018
- Study completionDec 2018
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 Body WeightStudies 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928653
- Sponsor's protocol ID
- 055-044
- Acronym
- LCS
- Status last verified
- Mar 2019
- First submitted
- 5 Oct 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Higgins KA, Mattes RD. A randomized controlled trial contrasting the effects of 4 low-calorie sweeteners and sucrose on body weight in adults with overweight or obesity. Am J Clin Nutr. 2019 May 1;109(5):1288-1301. doi: 10.1093/ajcn/nqy381.
PubMed 30997499
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
- ClinicalTrials.gov ID
- NCT02928653
- Acronym / sponsor ID
- LCS / 055-044
- Conditions
- Body Weight
- Keywords
- energy intake, energy expenditure, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Oct 2016 (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 aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sucrose Sweetened Beverage | Active comparator | Dietary Supplement: Beverage100-140 g sucrose/day |
| Aspartame Sweetened Beverage | Experimental | Dietary Supplement: Beverage0.541-0.757 g aspartame Sweetened Beverage/day |
| Saccharin Sweetened Beverage | Experimental | Dietary Supplement: Beverage0.300-0.455 g saccharin Sweetened Beverage/day |
| Sucralose Sweetened Beverage | Experimental | Dietary Supplement: Beverage0.167-0.233 g sucralose Sweetened Beverage/day |
| Rebaudioside A Sweeteened Beverage | Experimental | Dietary Supplement: Beverage0.250-0.350 g rebaudioside A Sweetened Beverage/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 25-40 kg/M2
- Non or rare users of LCS
- Willing to consume large volumes of beverages daily
Key exclusion criteria (4 listed)
- Weight change > 3kg in the last year
- Plan to initiate a new diet plan in the next 6 months
- Exhibit eating restraint
- Pregnant/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 |
|---|---|---|
| BeverageParticipants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks | Dietary supplement | Aspartame Sweetened Beverage, Rebaudioside A Sweeteened Beverage, Saccharin Sweetened Beverage, Sucralose Sweetened Beverage, Sucrose Sweetened Beverage |
Primary outcome
Body Weight
Time frame: 12 weeks
Body Composition
Time frame: 12 weeks
Duel emission X-ray absorbtiometry
Energy Intake
Time frame: 12 weeks
24 hr Dietary Recall
Appetite
Time frame: 12 weeks
24 hr visual analog scale appetite
Energy Expenditure
Time frame: 12 weeks
accelerometer
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 21 Mar 2019.
- Derived from this study: PubMed 30997499Higgins KA, Mattes RD. A randomized controlled trial contrasting the effects of 4 low-calorie sweeteners and sucrose on body weight in adults with overweight or obesity. Am J Clin Nutr. 2019 May 1;109(5):1288-1301. doi: 10.1093/ajcn/nqy381.
- Individual participant dataSharing planned: Undecided
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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.
Richard D Mattes, PhD principal investigator
Purdue 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 Beverage in people with Body Weight, run by Purdue 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 3 inclusion and 4 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 21 Mar 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?
Body Weight (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT02928653, 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 21 Mar 2019.