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Completed

NCT Number: NCT01304004

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

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.

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Satiety

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Change in energy intake at lunch

    Time frame: Mesured 2 times (during the 2 satiety tests, separeted by four weeks)

    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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Aliments ULTIMA Foods Inc.

Registry information

Acronym: JIVAGO

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Feb 25, 2011
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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