Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety (JIVAGO)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Satiety
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Yogurt, Proteins, Fibres, Women, Satiety
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant women
- Subjects taking medications for hypertension, depression, hyperlipidemia or immunosuppressant
- Allergy or intolerance to dairy products
- Vegetarism
Sites / Locations
- Institute of Nutraceutical and Functional Foods (INAF), Laval University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental drinking yogurt
Placebo drinking yogurt
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01304004
First Posted
February 22, 2011
Last Updated
January 22, 2013
Sponsor
Laval University
Collaborators
Aliments ULTIMA Foods Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01304004
Brief Title
Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety
Acronym
JIVAGO
Official Title
Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Aliments ULTIMA Foods Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Yogurt, Proteins, Fibres, Women, Satiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental drinking yogurt
Arm Type
Experimental
Arm Title
Placebo drinking yogurt
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Satiety
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in satiety
Description
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.
Time Frame
Mesured by analogue visual scales at each 30 minutes during 4 hours (for the 2 satiety tests, separeted by four weeks)
Secondary Outcome Measure Information:
Title
Change in energy intake at lunch
Description
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.
Time Frame
Mesured 2 times (during the 2 satiety tests, separeted by four weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant women
Subjects taking medications for hypertension, depression, hyperlipidemia or immunosuppressant
Allergy or intolerance to dairy products
Vegetarism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît LAmarche, PhD
Organizational Affiliation
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutraceutical and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
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Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety
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