Protocol summary

Summary
The aim of this study is determination the effect of probiotic yogurt on performance and health status of young adult women endurance swimmers. In a randomized controlled trial 46 girl endurance swimmers aged 11 to 17 years who had taken part in the national 400 and 800 meter crawl swimming competitions of 2009 will be studied. Subjects will be randomly assigned to two groups, receiving daily for 8 weeks, either 400 ml probiotic yogurt (intervention) or ordinary yogurt (control). At the beginning and at the end of the study, the 400-m free swimming record will be determined and the Harvard Step test will be employed to measure VO2max.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122311849N1
Registration date: 2013-01-19, 1391/10/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-19, 1391/10/30
Registrant information
Name
Nahid Salarkia
Name of organization / entity
National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Te
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7486
Email address
n.salarkia@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
International Branch, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2009-06-21, 1388/03/31
Expected recruitment end date
2009-08-22, 1388/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Probiotic yogurt effects on performance, respiratory and digestive system of endurance adolescent female swimmers
Public title
Probiotic yogurt effects on health status and performance of endurance adolescent female swimmer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :being healthy; having the 400 meter crawl swimming time less than 6 min. 20 Sec . Exclusion criteria: acute gastrointestinal symptoms ; intake antibiotics for two months before the study.
Age
From 11 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
NA

Health conditions studied

1

Description of health condition studied
Performance and respiratory and digestive disease
ICD-10 code
J00,J02,J0
ICD-10 code description
common cold, Sore throat, Influenza, Gastro-oesophageal reflux disease

Primary outcomes

1

Description
VO2max
Timepoint
Harvard Step test will be employed to measure VO2max will be performed at the beginning and end of week eight
Method of measurement
Harvard Step test will be employed to measure VO2max. The athlete step up and down off a 41cm high bench for 3 minutes at a rate 22 steps/minute. On finishing the test the number of heart beats will be counted for 15 seconds. The number of beats will be multiplied in 15 seconds by 4 to give the "step test pulse rate". This final value will be used to assess the athlete's VO2max in ml/kg/min.

Secondary outcomes

1

Description
stomachache, vomiting and diarrhea; respiratory infections such as: rhinitis, fever, sore throat, cough, chest ailing breath by sound, ear pain
Timepoint
at the beginning and end of week eight
Method of measurement
All subjects will be asked to record the digestive symptoms such as: stomachache, vomiting and diarrhea; respiratory infections such as: rhinitis, fever, sore throat, cough, chest ailing breath by sound, ear pain; the extent of exercise per meter; the intake of medicine and quantity of the consumed foodstuff product which had been recommended, on the provided questionnaires, daily. The subjects will be advised to refrain from other probiotic products which were outside the project plan

Intervention groups

1

Description
Intervention group : Receiving 400 ml yogurt Probiotic containing 4 × 1010 cfu/ml (Colony forming unit per millimeter) comprising of Lactobacillus Acidophilus SPP, Lactobacillus Delbrueckii Bulgaricus, Bifidobacterium Bifidum, and Streptococcus Salivarus Thermnophilus, (n=23) and group
Category
Prevention

2

Description
Control group: Receiving similar dose of ordinary yogurt
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
National Nutrition and Food Technology Research Institute
Full name of responsible person
Nahid Salarkia-Leili Ghadamli
Street address
46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
self financial
Full name of responsible person
Leili Ghadamli
Street address
International Branch, Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
self financial
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
self financial
Full name of responsible person
Leili Ghadamli
Street address
nternational Branch, Shahid Beheshti University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
self financial
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
, International Branch, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Leili Ghadamli
Position
M.Sc in Nutrition Sciences
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Fax
Email
leylee61@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Te
Full name of responsible person
Nahid Salarkia
Position
Assistant Research
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Fax
Email
n_salarkia@hotmail.com, nahidsalarkia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Te
Full name of responsible person
Nahid Salarkia
Position
Assistant Research
Other areas of specialty/work
Street address
46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7486
Fax
+98 21 2237 6470
Email
n_salarkia@hotmail.com nahidsalarkia@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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