ObesityJIVAGONCT01304004
Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety
A study testing Satiety in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
Worldwide, obesity rate has increased so much in the latest years, that we call it obesity epidemic. Overweight could result of an unbalanced energetic balance for years. The person who regularly consumes more calories than she expends will find herself with a positive energetic balance, which results in a weight… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Satiety
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Dec 2011
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged between 25 and 45 years old
- Body mass index between 20 and 30 kg/m2
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Who cannot join
- Previous history of cardiovascular disease, type 2 diabetes and other endocrine disorders
- High blood pressure (≥ 140/90)
- Previous history of repeated weight loss and weight gain
- Important weight loss during the 6 months before the beginning of the study
- Subjects with high restriction level according to established criteria of a questionnaire that measures restriction level
- Use of natural products or supplements having effects on dietary intake during the 3 months
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- Pregnant women
- Subjects taking medications for hypertension, depression, hyperlipidemia or immunosuppressant
- Allergy or intolerance to dairy products
- Vegetarism
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
Worldwide, obesity rate has increased so much in the latest years, that we call it obesity epidemic. Overweight could result of an unbalanced energetic balance for years. The person who regularly consumes more calories than she expends will find herself with a positive energetic balance, which results in a weight gain. A daily overconsumption of only 10 calories comes with a weight gain throughout one year. A way to avoid this overconsumption is to eat food that increases satiety. Satiety can be defined as the time interval after food ingestion, during which hunger and desire to eat are suppressed.
The general objective of the study is to investigate in a pilot study the impact of a drinkable yogurt enriched in proteins and fibres on satiety.
Read the detailed description
The study will be conducted according to an estimate crossover randomized double-blind and include two treatments to drink that will be tested in each one month apart.
- Experimental drinkable yogurt enriched in proteins and fibres
- Placebo drinkable yogurt (isocaloric and isovolumetric)
One the eve of the two tests, participants will consume the same meal at dinner time. During the test days, participants should arrive between 6:30 and 8:30 and will be isolated in a private room suitable for this type of testing. Any reference to time of the day will be eliminated until the end of tests. First, participants will consume a standardized breakfast which corresponds to about 10 to 15% of energy needs of the day. The food provided at breakfast (toast, butter, peanut butter, cheese, orange juice) will be the same in both tests. Participants must consume all food within a period of 15 minutes. Two hours after the start of the test, participants will receive a snack in the form of yogurt (experimental, placebo) they will consume within a period of 5 minutes. Two hours later, participants will receive a lunch buffet consists of food ready to eat. The foods present in the buffet will have an overall energy value of about 1500 kcal, which exceeds the energy needs of participants for this meal. They will be encouraged to consume foods until satiety over a maximum of 30 minutes.
Satiety will be measured by visual analogue scale throughout the test, either immediately before breakfast and snack as well as predetermined times thereafter until the lunch. Participants will have access to water throughout the test. The weight of food consumed and the water intake will be calculated in the absence of the participants and will be used to calculate the energy intake at lunch.
- Conditions
- Obesity
- Being tested
- Satiety
- Keywords
- Obesity, Yogurt, Proteins, Fibres, Women, Satiety
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SatietyOther
Intervention Description: Consumption of the 2 drinkable yogurts separated by 4 weeks:
- Experimental drinkable yogurt enriched in proteins and fibres
- Placebo drinkable yogurt (isocaloric and isovolumetric)
| Study group | Role | What they receive |
|---|---|---|
| Experimental drinking yogurt | Experimental | Not described Receives: Other: Satiety |
| Placebo drinking yogurt | Placebo comparator | Not described Receives: Other: Satiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in satiety
Satiety will be measured by visual analogue scales throughout the test, either immediately before breakfast and snack as well as predetermined times thereafter until the lunch.
Measured: Mesured by analogue visual scales at each 30 minutes during 4 hours (for the 2 satiety tests, separeted by four weeks)
Secondary outcomes (1)
Change in energy intake at lunch
The weight of food consumed and the water intake during the two satiety tests will be calculated in the absence of the participants and will be used to calculate the energy intake at lunch.
Measured: Mesured 2 times (during the 2 satiety tests, separeted by four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Aliments ULTIMA Foods Inc.
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Benoît LAmarche, PhD, Principal investigator, Institute of Nutraceutical and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304004
- Sponsor's protocol ID
- INAF-2010-154
- Acronym
- JIVAGO
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety
- ClinicalTrials.gov ID
- NCT01304004
- Acronym / sponsor ID
- JIVAGO / INAF-2010-154
- Conditions
- Obesity
- Keywords
- Obesity, Yogurt, Proteins, Fibres, Women, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Aliments ULTIMA Foods Inc.
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2011 (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.
Worldwide, obesity rate has increased so much in the latest years, that we call it obesity epidemic. Overweight could result of an unbalanced energetic balance for years. The person who regularly consumes more calories than she expends will find herself with a positive energetic balance, which results in a weight gain. A daily overconsumption of only 10 calories comes with a weight gain throughout one year. A way to avoid this overconsumption is to eat food that increases satiety. Satiety can be defined as the time interval after food ingestion, during which hunger and desire to eat are suppressed.
The general objective of the study is to investigate in a pilot study the impact of a drinkable yogurt enriched in proteins and fibres on satiety.
Detailed description
The study will be conducted according to an estimate crossover randomized double-blind and include two treatments to drink that will be tested in each one month apart.
- Experimental drinkable yogurt enriched in proteins and fibres
- Placebo drinkable yogurt (isocaloric and isovolumetric)
One the eve of the two tests, participants will consume the same meal at dinner time. During the test days, participants should arrive between 6:30 and 8:30 and will be isolated in a private room suitable for this type of testing. Any reference to time of the day will be eliminated until the end of tests. First, participants will consume a standardized breakfast which corresponds to about 10 to 15% of energy needs of the day. The food provided at breakfast (toast, butter, peanut butter, cheese, orange juice) will be the same in both tests. Participants must consume all food within a period of 15 minutes. Two hours after the start of the test, participants will receive a snack in the form of yogurt (experimental, placebo) they will consume within a period of 5 minutes. Two hours later, participants will receive a lunch buffet consists of food ready to eat. The foods present in the buffet will have an overall energy value of about 1500 kcal, which exceeds the energy needs of participants for this meal. They will be encouraged to consume foods until satiety over a maximum of 30 minutes.
Satiety will be measured by visual analogue scale throughout the test, either immediately before breakfast and snack as well as predetermined times thereafter until the lunch. Participants will have access to water throughout the test. The weight of food consumed and the water intake will be calculated in the absence of the participants and will be used to calculate the energy intake at lunch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental drinking yogurt | Experimental | Other: Satiety |
| Placebo drinking yogurt | Placebo comparator | Other: Satiety |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy women aged between 25 and 45 years old
- Body mass index between 20 and 30 kg/m2
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Key exclusion criteria (10 listed)
- Previous history of cardiovascular disease, type 2 diabetes and other endocrine disorders
- High blood pressure (≥ 140/90)
- Previous history of repeated weight loss and weight gain
- Important weight loss during the 6 months before the beginning of the study
- Subjects with high restriction level according to established criteria of a questionnaire that measures restriction level
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 |
|---|---|---|
| SatietyIntervention Description: Consumption of the 2 drinkable yogurts separated by 4 weeks: 1. Experimental drinkable yogurt enriched in proteins and fibres 2. Placebo drinkable yogurt (isocaloric and isovolumetric) | Other | Experimental drinking yogurt, Placebo drinking yogurt |
Primary outcome
Change in satiety
Time frame: Mesured by analogue visual scales at each 30 minutes during 4 hours (for the 2 satiety tests, separeted by four weeks)
Satiety will be measured by visual analogue scales throughout the test, either immediately before breakfast and snack as well as predetermined times thereafter until the lunch.
1 secondary outcome
Change in energy intake at lunch
Time frame: Mesured 2 times (during the 2 satiety tests, separeted by four 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 23 Jan 2013.
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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.
Benoît LAmarche, PhD principal investigator
Institute of Nutraceutical and Functional Foods (INAF), Laval 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 Satiety in people with Obesity, run by Laval University at 1 site in Canada.
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 4 inclusion and 10 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 23 Jan 2013. 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 Canada. 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. Some participants in this study may receive a placebo. 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 satiety (time frame: Mesured by analogue visual scales at each 30 minutes during 4 hours (for the 2 satiety tests, separeted by four weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2013.