The effects of acute and short-term supplementation of choline on responses of the autonomic and hemodynamic system to sprint interval exercise in overweight and obese individuals
The effects of acute and short-term supplementation of choline on responses of the autonomic and hemodynamic system to sprint interval exercise in overweight and obese individuals
Design
The study will be conducted by a single group (12 participants) consuming both choline supplements and placebo in a randomized (Using a random number table), double-blind cross-over design in two phases. The participants will acutely consume 1000 mg of choline supplement in the first phase and then perform an exercise test. In the second phase, participants will take 600 mg of choline supplement for seven days and then repeat the exercise test.
Settings and conduct
The study will be conducted to evaluate choline's influences on cardiac autonomic function in the exercise physiology laboratory of Shahid Beheshti University. An independent coordinator who will not be involved in the study will assign the participant to supplement or placebo.
Participants/Inclusion and exclusion criteria
body mass index (BMI) > 27, no regular exercise/physical activity in the last year, nonsmoker, no alcohol consumption in the last two months, and no experiences or diagnosed illness (Hypertension, diabetes, etc.), especially cardiovascular diseases.
Intervention groups
Participants will consume a single dose of choline (1000 mg) or placebo supplement in the first phase and then perform an exercise test. In the second phase, the similar group will take 600 mg of choline or placebo for seven days and then repeat the exercise test. The study's variables (Heart rate variability and hemodynamic indices) will be measured before and after supplement or placebo consumption and following 120 min (every 15 min) after the exercise test.
The effects of acute and short-term supplementation of choline on responses of the autonomic and hemodynamic system to sprint interval exercise in overweight and obese individuals
Public title
The effect of choline supplement on autonomic system
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
body mass index (BMI) > 27
no regular exercise/physical activity in the last year according to the recommendation of the American College of Sport Medicine for exercise (150 min moderate-intensity exercise or 75 min vigorous exercise per week)
nonsmoker
no alcohol consumption in the last two month
no experiences or diagnosed illness (Hypertension, diabetes, etc.), especially cardiovascular diseases
Exclusion criteria:
If they used high choline diets (According to 48 hours food frequency questioner)
dietary supplements, or medication that could affect the study's cardiac autonomic function and hemodynamics variables
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant will be taking part in both supplement and placebo groups. Thus two samples will be taken from them.
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a single group in a randomized cross-over design for the study. The participants will be allocated randomly (Using a random number table) to supplement or placebo groups in the first week. Following a one-week wash-out, the placebo participants will use the supplement, and those who consumed the supplement will use the placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be performed in a double-blind design which non of the authors, researchers who will be involved in this study, and the participants will not know about the supplement or placebo consumption. An independent coordinator who will not be involved in the study will assign participants randomly to the supplement or placebo groups.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University
The cardiac autonomic system of overweight or obese women with body mass index (BMI) 27<, and their age be between 20 to 40.
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Heart rate variability (HRV): Changes in heart rate signals in the time interval between two consecutive heartbeats that are recorded using a heart rate Holter device and represent the quality of the cardiac autonomic system and the time-based method (domain time) frequency-based (frequency domain) is used to measure it. The main HRV variables in the current study will be included: Standard Deviation of RR wave intervals (SDNN), high frequency (HF), low frequency (LF), the ratio of LF to HF (LF/HF) bands, and percentage of interval differences of adjacent RR intervals greater than 50 ms (pNN50).
Timepoint
In the acute phase, the HRV variables will be measured before using choline supplement or placebo, 60 min after consuming choline supplement or placebo, immediately after the exercise test, 120 min following it (every 15 min). In the chronic phase, the HRV variables will be measured before starting consuming choline or placebo for seven days, after seven days, before using the last dose of choline or placebo on the seventh day, 60 min after consuming choline or placebo, immediately after the exercise test, 120 min following it (every 15 min).
Method of measurement
myPatch®sl Holter monitor (dms-service, made in USA)
2
Description
Hemodynamic variables which in the current study will be included: systolic blood pressure and diastolic blood pressure.
Timepoint
In the acute phase, the hemodynamic variables will be measured before using choline supplement or placebo, 60 min after consuming choline supplement or placebo, immediately after the exercise test, 120 min following it (every 15 min). In the chronic phase, the hemodynamic variables will be measured before starting consuming choline or placebo for seven days, after seven days, before using the last dose of choline or placebo on the seventh day, 60 min after consuming choline or placebo, immediately after the exercise test, 120 min following it (every 15 min).
Method of measurement
Automatic Arm Blood Pressure Monitor JPN500, OMRON. Made in Japan.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will consume Alpha-GPC Choline supplement in acute (single dose) and chronic (seven days) phases. Participants will consume Alpha-GPC Choline (1000 mg) which will be dissolved in 250 ml of water after eating breakfast in the acute phase. In the second phase, participants will consume 600 mg of Alpha-GPC (Two capsules per day) with their meals for six days in the morning and evening. Participants will arrive at the laboratory on the seventh day between 7:30 and 8:00 in a fasting state (12 h). After measuring the autonomic and hemodynamic variables, the final dose of Choline (600 mg) will be taken.
Category
Prevention
2
Description
Control group: The same participants with one-week intervals will be used as a control group. The control group will consume a placebo in acute (single dose) and chronic (seven days) phases. Participants will consume a placebo which will be dissolved in 250 ml of water with a similar color and flavor with choline supplement after eating breakfast in the acute phase. In the second phase, participants will consume two capsules (similar color and flavor with choline supplement) of placebo with their meals for six days in the morning and evening. Participants will arrive at the laboratory on the seventh day between 7:30 and 8:00 in a fasting state (12 h). After measuring the autonomic and hemodynamic variables, the final dose of placebo (600 mg) will be taken.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Biological Sciences in Sport, Faculty of Sport Sciences and Health, Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 5821
Fax
+98 21 2243 1953
Email
s_ahmadizad@sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Biological Sciences in Sport, Faculty of Sport Sciences and Health, Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 5821
Email
s_ahmadizad@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Biological Sciences in Sport, Faculty of Sport Sciences and Health, Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 5821
Email
s_ahmadizad@sbu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The study's data and supplementary information will be available after making personal information of participants unrecognizable whenever they are requested
When the data will become available and for how long
The current study's data will be available immediately after publishing.
To whom data/document is available
The study's data and supplementary information will be available for both people working in academic institutions and people working in businesses whenever they request them.
Under which criteria data/document could be used
The study's data and supplementary information will be available publicly. However, those who want to use them should respect copyright, do not manipulate them, and cite the study's original articles which will be published.
From where data/document is obtainable
The raw data and supporting information of this study will be available by request of the corresponding author, without undue reservation. The corresponding author is Professor Sajad Ahmadizad, Department of Biological Sciences in Sport, Faculty of Sports Sciences and Health, Shahid Beheshti University, Velenjak, Tehran, Iran.
Email: s_ahmadizad@sbu.ac.ir.
Postcode: 1983963113
Tel: 0098-21-29905821
Fax: 0098-21-22431953
What processes are involved for a request to access data/document
This study's raw data and supporting information will be available up to two weeks after the request.