Eating BehaviorNCT02297880
Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety
A study testing Beverage containing low calorie sweeteners and Still water in people with Eating Behavior, run by The Coca-Cola Company at 1 site in France.
Trial summary
Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Beverage containing low calorie sweeteners and Still water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index: Lower limit 18 kg/m²; Upper limit 28 kg/m²; weight stable within ± 3 kg in the last 6 months
- Habitual energy intake within the 95% confident interval of the reference energy intake for the French population (as provided by the INCA 2 survey
- Must not be a regular drinker of LCS beverages (less than once a week no more than every 15 days) and be willing to use LCS according to protocol
- For female participants: not pregnant, not breast feeding, planning to become pregnant during the study or on contraception since at least 3 months (regular 28-day cycle)
- Subject registered with the French Social Security.
Who cannot join
- Currently diagnosed somatic pathology
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months
- Major psychiatric disorder, particularly eating disorders as defined by the Diagnostic and Statistical Manual od Mental Disorders-IV
- Rejection of sweet foods or drinks as revealed by the diet history
- Smoking subject planning to stop smoking in the next 3 months
- Subjects suffering from food allergies or intolerance
- Subject not capable of understanding the constraints of the study and who not agree to abide
Trial locations and contacts
1 site in 1 country.
France1 site
CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming
Givors, Lyon, 69700
About this study
Official title: Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations
Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.
Read the detailed description
The study will be a monocentric randomized controlled open trial including two parallel groups to examine effects of LCS beverages as compared to water on daily intakes of energy and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the selection of sweet or savory foods eating occasions will be assessed.
- Conditions
- Eating Behavior
- Being tested
- Beverage containing low calorie sweeteners, Still water
- Keywords
- low calorie sweetener satiety, intake, hunger
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage containing low calorie sweetenersOther
Beverage containing low calorie sweeteners
Still waterOther
Still water (no flavour)
| Study group | Role | What they receive |
|---|---|---|
| Beverage containing low calorie sweeteners | Experimental | Beverage containing low calorie sweeteners (flavour) Receives: Other: Beverage containing low calorie sweeteners |
| Still water | Active comparator | Still water (no flavour) Receives: Other: Still water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sensations: hunger, satiety and desire to eat
Visual Analog Scales
Measured: 9 weeks
Secondary outcomes (2)
Energy and macronutrient intakes
Diet history questionnaire
Measured: 9 weeks
Anthropometric parameters
body weight, height, waist and hip circumferences
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 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 Eating BehaviorStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Coca-Cola Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CreaBIO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297880
- Sponsor's protocol ID
- CreaBIO1
- Status last verified
- Feb 2017
- First submitted
- 13 Nov 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fantino M, Fantino A, Matray M, Mistretta F. Beverages containing low energy sweeteners do not differ from water in their effects on appetite, energy intake and food choices in healthy, non-obese French adults. Appetite. 2018 Jun 1;125:557-565. doi: 10.1016/j.appet.2018.03.007. Epub 2018 Mar 9.
PubMed 29526693
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations
- ClinicalTrials.gov ID
- NCT02297880
- Acronym / sponsor ID
- CreaBIO1
- Conditions
- Eating Behavior
- Keywords
- low calorie sweetener satiety, intake, hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The Coca-Cola CompanyIndustry (pharma, biotech, devices)
- Collaborators
- CreaBIO
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Nov 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.
Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.
Detailed description
The study will be a monocentric randomized controlled open trial including two parallel groups to examine effects of LCS beverages as compared to water on daily intakes of energy and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the selection of sweet or savory foods eating occasions will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beverage containing low calorie sweeteners | Experimental | Other: Beverage containing low calorie sweetenersBeverage containing low calorie sweeteners (flavour) |
| Still water | Active comparator | Other: Still waterStill water (no flavour) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index: Lower limit 18 kg/m²; Upper limit 28 kg/m²; weight stable within ± 3 kg in the last 6 months
- Habitual energy intake within the 95% confident interval of the reference energy intake for the French population (as provided by the INCA 2 survey
- Must not be a regular drinker of LCS beverages (less than once a week no more than every 15 days) and be willing to use LCS according to protocol
- For female participants: not pregnant, not breast feeding, planning to become pregnant during the study or on contraception since at least 3 months (regular 28-day cycle)
- Subject registered with the French Social Security.
Key exclusion criteria (7 listed)
- Currently diagnosed somatic pathology
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months
- Major psychiatric disorder, particularly eating disorders as defined by the Diagnostic and Statistical Manual od Mental Disorders-IV
- Rejection of sweet foods or drinks as revealed by the diet history
- Smoking subject planning to stop smoking in the next 3 months
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 |
|---|---|---|
| Beverage containing low calorie sweetenersBeverage containing low calorie sweeteners | Other | Beverage containing low calorie sweeteners |
| Still waterStill water (no flavour) | Other | Still water |
Primary outcome
Subjective sensations: hunger, satiety and desire to eat
Time frame: 9 weeks
Visual Analog Scales
2 secondary outcomes
Energy and macronutrient intakes
Time frame: 9 weeks
Anthropometric parameters
Time frame: 9 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 9 Feb 2017.
- Derived from this study: PubMed 29526693Fantino M, Fantino A, Matray M, Mistretta F. Beverages containing low energy sweeteners do not differ from water in their effects on appetite, energy intake and food choices in healthy, non-obese French adults. Appetite. 2018 Jun 1;125:557-565. doi: 10.1016/j.appet.2018.03.007. Epub 2018 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 containing low calorie sweeteners and Still water in people with Eating Behavior, run by The Coca-Cola Company at 1 site in France.
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 7 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 9 Feb 2017. 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 France. 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?
Subjective sensations: hunger, satiety and desire to eat (time frame: 9 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 NCT02297880, 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 9 Feb 2017.