Text Size

Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety (JIVAGO)

This study has been completed.
Sponsor:
Collaborator:
Ultima Food Inc
Information provided by (Responsible Party):
Benoit Lamarche, Laval University
ClinicalTrials.gov Identifier:
NCT01304004
First received: February 22, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: Satiety

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Drinkable Yogurt Enriched in Proteins and Fibers on Satiety

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Mesured 2 times (during the 2 satiety tests, separeted by four weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental drinking yogurt Other: Satiety

Intervention 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)
Placebo Comparator: Placebo drinking yogurt Other: Satiety

Intervention 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)

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.

  1. Experimental drinkable yogurt enriched in proteins and fibres
  2. 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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304004

Locations
Canada
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Ultima Food Inc
Investigators
Principal Investigator: Benoît LAmarche, PhD Institute of Nutraceutical and Functional Foods (INAF), Laval University
  More Information

No publications provided

Responsible Party: Benoit Lamarche, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01304004     History of Changes
Other Study ID Numbers: INAF-2010-154
Study First Received: February 22, 2011
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Obesity
Yogurt
Proteins
 Fibres
Women
Satiety

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013