Protocol summary

Summary
purpose: The aim of this study is to compare the effect of two meals with high or low glycemic load on exercise performance and glycemic response in female athletes. Materials and methods: thirty six non-professional female athletes, aged 19-24 years were enrolled in a cross-over double-blind randomized clinical trial. Participants in each group received a high or low glycemic load meal as a breakfast, and 7-day wash out period is determined. Serum glucose and insulin measurements were performed before and after each phase of intervention. 3 hours after ingestion of meal, subjects ran up to exhaustion, in a 20 meters shuttle run pacer. Results: the ingestion of a high or low glycemic load meal 3 hours before exercise did not lead to significant difference in exercise performance. But mean changes in serum glucose and insulin in the meal with high glycemic load was higher than the meal with low glycemic load. Conclusion: consumption of a meal with high glycemic load, 3 hours before a 20 meters shuttle run pacer, increased serum glucose and insulin levels during exercise compared with a meal with low glycemic load.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508185062N9
Registration date: 2015-09-29, 1394/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-29, 1394/07/07
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Food Security Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between high or low glycemic load pre-exercise meals intake on glycemic response in female athletes: a cross-over feeding trial
Public title
Glycemic load meals effect on glycemic response
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: females with ages between 19 and 24 years; BMI between 19 and 24 Kilograms per square meter; having a regular exercise program, three times a week for 90 minute Exclusion criteria: having history of any chronic diseases; pregnancy or lactating status ; taking any medications or supplements.
Age
From 19 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Not

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, hezar grib street, Isfahan, Iran
City
Isahan
Postal code
Approval date
2014-05-04, 1393/02/14
Ethics committee reference number
292083

Health conditions studied

1

Description of health condition studied
athletes
ICD-10 code
Z71.2
ICD-10 code description
مشاوره فردی برای توضیح یافته های تحقیق

Primary outcomes

1

Description
blood sugar and insulin
Timepoint
Once in the first phase and the second phase next 7 days
Method of measurement
blood glucose with glucose oxidase method using biochemical autoanalyzer and insulin using ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Subjects randomly assigned into high or low GL group. Nineteen individuals participated in each group. They received high or low GL meals as their breakfast, and after 7 days as a wash out period, participants in each group received alternative meals
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Stadium shahid movahedi, Isfahan University of Medical Sciences
Full name of responsible person
Zinat Sharifhosein
Street address
Stadium shahid movahedi, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Food Security Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mrs doctor azadbakht
Street address
Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Security Research Center, Isfahan University of Medical Sciences
Proportion provided by this source
100
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
Isfahan university of Medical Sciences, School of Nutrition and Food Sciences
Full name of responsible person
Reza Ghiasvand
Position
Faculty member
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Isfahan university of Medical Sciences, hezar gerib street, Isfahan, Iran
City
Isfahan
Postal code
00983137923153
Phone
+98 31 3792 3153
Fax
Email
ghiasvand@hlth.mui.ac.irrghiasvand@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Zinat Sharifhosein
Position
MSc
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Isfahan university of Medical Sciences, hezar gerib street, Isfahan, Iran
City
Isfahan
Postal code
00983137923152
Phone
+98 31 3792 3152
Fax
Email
zsharifhosein@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zinat Sharifhosein
Position
MSc
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Isfahan university of Medical Sciences, hezar gerib street, Isfahan, Iran
City
Isfahan
Postal code
Phone
00
Fax
Email
zsharifhosein@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
empty
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