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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 0A6
    • Institute of Nutraceutical and Functional Foods (INAF), Laval University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental drinking yogurt	Other: Satiety; 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)
Placebo Comparator: Placebo drinking yogurt	Other: Satiety; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Mesured by analogue visual scales at each 30 minutes during 4 hours (for the 2 satiety tests, separeted by four weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Mesured 2 times (during the 2 satiety tests, separeted by four weeks)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Aliments ULTIMA Foods Inc.
• Investigators: Principal Investigator: Benoît Lamarche, PhD, Institute of Nutraceutical and Functional Foods (INAF), Laval University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Women; Satiety; Proteins; Yogurt; Fibres
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: INAF-2010-154