NCT00729170

Brief Summary

The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

1.9 years

First QC Date

August 5, 2008

Last Update Submit

June 29, 2012

Conditions

ObesityOsteoporosis

Keywords

MilkCalciumWeight lossBone densityAppetite

Outcome Measures

Primary Outcomes (1)

  • Body composition (body weight, fat mass, anthropometric measurements)

    Baseline, month 1, and month 6

Secondary Outcomes (2)

  • Bone density (DXA)

    Baseline and month 6

  • Appetite sensations

    Baseline, month 1, and month 6

Interventions

Supplementation of milk (35% more calcium)DIETARY_SUPPLEMENT

The supplement provides 1000 mg of calcium and 250 kcal daily.

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low-calcium consumer (less than 800 mg daily)
  • BMI between 27 to 42 kg/m2
  • Sedentary
  • Healthy

You may not qualify if:

  • In menopause
  • Medications that alter the project's objectives
  • Smoker
  • Dietary supplement consumer
  • High alcohol or caffeine consumer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche de l'Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Gilbert JA, Joanisse DR, Chaput JP, Miegueu P, Cianflone K, Almeras N, Tremblay A. Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial. Br J Nutr. 2011 Jan;105(1):133-43. doi: 10.1017/S0007114510003119.

    PMID: 21205360DERIVED

MeSH Terms

Conditions

ObesityOsteoporosisWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesBody Weight Changes

Study Officials

  • Angelo Tremblay, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

  • Denis R Joanisse, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 7, 2008

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

February 1, 2009

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

CA(1)