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IRCT20160606028290N2 IRCT 2022-02-15 Shahid Beheshti University The effect of choline supplement on autonomic system 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 2022-04-09 anticipated 12 Complete https://irct.ir/trial/61823 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, 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 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. N/A The cardiac autonomic system of overweight or obese women with body mass index (BMI) 27<, and their age be between 20 to 40.. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The study's data and supplementary information will be available after making personal information of participants unrecognizable whenever they are requested When: The current study's data will be available immediately after publishing. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: This study's raw data and supporting information will be available up to two weeks after the request. Comments:
public Sajad Ahmadizad
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
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 5821 s_ahmadizad@sbu.ac.ir Shahid Beheshti University scientific Sajad Ahmadizad
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
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 5821 s_ahmadizad@sbu.ac.ir Shahid Beheshti University Iran (Islamic Republic of) 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 20 years 40 years Female 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 E66 Overweight and obesity Prevention Prevention 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. 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. 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). 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. Shahid Beheshti University Approved 2022-01-15 Research Ethics Committees of Shahid Beheshti University Evin, Shahid Shahriari Square, Shahid Beheshti University, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)