NCT01304004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

February 22, 2011

Last Update Submit

January 22, 2013

Conditions

Obesity

Keywords

ObesityYogurtProteinsFibresWomenSatiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in energy intake at lunch

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

Study Arms (2)

Experimental drinking yogurt

EXPERIMENTAL
Other: Satiety

Placebo drinking yogurt

PLACEBO COMPARATOR
Other: Satiety

Interventions

SatietyOTHER

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)

Experimental drinking yogurtPlacebo drinking yogurt

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benoît LAmarche, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 25, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

CA(1)