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IRCT20200411047036N1 IRCT 2020-06-05 The University of Tabriz Effect of training, caloric restriction and vitamin D supplementation on body composition, lipid profile and plasma BDNF Effect of four-week Water Aerobics training with and without caloric restriction and vitamin D supplementation on body composition, lipid profile and peripheral blood BDNF in adult females with overweight and obesity 2018-09-06 anticipated 80 Complete https://irct.ir/trial/47125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, indivitual randomization unit, using random numbers table. Numbers 01-10 for the water exercise group, Numbers 11-20 for the water exercise + calorie restriction group, Numbers 21-30 for the water exercise + Vitamin D supplementation group and Numbers 31-40 for the water exercise + Caloric restriction + Vitamin D supplementation group are considered in the researcher. Then the researcher close her/his eyes and select a number in the random numbers table and reads the first two numbers of that 5 digits number. for selecting other numbers researcher go through the column. The first 10 numbers witch those are smaller than 40 are allocated to the first group and continue this way to determine the samples of all groups. It should be noted that after assigning the samples to 4 groups, the homogeneity of the groups in terms of control variables is examined using SPSS software. Allocation concealment: To this porpuse the sequentially numbered, opaque, sealed envelopes (SNOPE) are used. In this way, after creating a random sequence, based on the sample size of the research (40 people), 40 envelopes with aluminum sheets (using aluminum sheets available in the market) are Prepared and each random sequence created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain random sequencing, numbering on the outer surface of the envelopes is done in the same way. Finally, the lids of the envelopes are pasted and placed inside the box, respectively. At the beginning of the registration process, one of the envelope papers will be opened in order, according to the order in which the eligible participants entered the study, and the assigned group of the partner will be revealed, Blinding description: Participants, by using placebo and recieving diet they have assumed that they all received the same intervention Reasercher,without any information and involvement in sample grouping. 3 Condition 1: overweight or obesity. Condition 2: Lipid profile (Triglycerides, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), Total cholesterol. Condition 3: Peripheral blood Brain-Drived Neurotrophic Factor. Intervention 1: Intervention group: Water Aerobic Training, 12 sessions in 1 to 1.5 hours, three times a week, subjects will intake a Vitamin D placebo everyday without any calorie restriction. In training days they will give a diet plan according their daily energy requirement+ exercise specific energy requirement and in other days a diet plan just according their daily energy requirement. Intervention 2: Intervention group: Water Aerobic Training (Training:12 sessions in 1 to 1.5 hours, three times a week)+ Caloric restriction (In training days they will give a 25% restricted diet according their daily energy requirement+ exercise specific energy requirement and in other days a 25% restricted diet just according their daily energy requirement.)They will intake a Vitamin D placebo everyday. Intervention 3: Intervention group: Water Aerobic Training (Training:12 sessions in 1 to 1.5 hours, three times a week)+ Vitamin D Supplementation (They will intake a 1000 U Vitamin D pearl everyday), without any calorie restriction. In training days they will give a diet plan according their daily energy requirement+ exercise specific energy. Intervention 4: Intervention group: Water Aerobic Training (12 sessions in 1 to 1.5 hours, three times a week)+ Caloric Restriction (In training days they will give a 25% restricted diet according their daily energy requirement+ exercise specific energy requirement and in other days a 25% restricted diet just according their daily energy requirement) + Vitamin D Supplementation (They will intake a 1000 U Vitamin D pearl everyday). Yes - There is a plan to make this available What will be shared: Only part of the data is possible When: Data will be accessible from september 2020 To whom: Only researchers will be able to access the data Conditions: Just to study more and get an idea of the research plan Where to obtain: Farhangifarhangi00@gmail.com How to obtain: Send a message to given email Comments:
public Dr.Afshar Jafari
Shahid Beheshti University, Tehran Province, Tehran, District 1, Daneshjou Boulevard
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 1962 afshar.jafari@gmail.com Shahid Beheshti University scientific Dr.Afshar Jafari
Shahid Beheshti University, Tehran Province, Tehran, District 1, Daneshjou Boulevard
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 1962 afshar.jafari@gmail.com Shahid Beheshti University Iran (Islamic Republic of) women between 30 and 50 age group BMI= 30-35 kg/m2 women should be in pre-menopausal period women should have 9 to 11 menstural cycle in year 30 years 50 years Female E66.0 E78.5 F32 Obesity due to excess calories Hyperlipidemia, unspecified Major depressive disorder, single episode Other Other Other Other Intervention group: Water Aerobic Training, 12 sessions in 1 to 1.5 hours, three times a week, subjects will intake a Vitamin D placebo everyday without any calorie restriction. In training days they will give a diet plan according their daily energy requirement+ exercise specific energy requirement and in other days a diet plan just according their daily energy requirement. Intervention group: Water Aerobic Training (Training:12 sessions in 1 to 1.5 hours, three times a week)+ Caloric restriction (In training days they will give a 25% restricted diet according their daily energy requirement+ exercise specific energy requirement and in other days a 25% restricted diet just according their daily energy requirement.)They will intake a Vitamin D placebo everyday Intervention group: Water Aerobic Training (Training:12 sessions in 1 to 1.5 hours, three times a week)+ Vitamin D Supplementation (They will intake a 1000 U Vitamin D pearl everyday), without any calorie restriction. In training days they will give a diet plan according their daily energy requirement+ exercise specific energy. Intervention group: Water Aerobic Training (12 sessions in 1 to 1.5 hours, three times a week)+ Caloric Restriction (In training days they will give a 25% restricted diet according their daily energy requirement+ exercise specific energy requirement and in other days a 25% restricted diet just according their daily energy requirement) + Vitamin D Supplementation (They will intake a 1000 U Vitamin D pearl everyday) Changes in serum Brain-Drived Neurotrophic Factor. Timepoint: Pre-test blood sampling of Brain-Drived Neurotrophic Factor performed on the eighth day of each woman's menstural cycle and Post-test performed on 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: Serum Brain-Drived Neurotrophic Factor Concentration measured by the Competitive Sandwich Enzyme-Linked Immunoorbent Assay (ELISA) Test Using Crystal Day Biotech Kit made in China. Waist circumference. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: From the upper abdomen measured by a tape measure and after a normal exhalation. Range of Body Mass Index. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: By dividing the weight in kilograms by the height of the meter. Fat percentage. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: By caliper tool and using Jackson-Pollock 3Point method. Body Fat Mass. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: By measuring weight and multiplying the percentage of fat by the amount of weight. Lean Body Mass. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: By eliminating the amount of fat mass from the amount of weight. Serum triglyceride levels. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: Using Enzymatic method. Serum High-Density Lipoprotein. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: Using Enzymatic method. Serum Ligh-Density Lipoprotein. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: Friedewald Formula. Serum Total Colestrol. Timepoint: Pre-test: the eighth day of each woman's menstural cycle Post-test: 48 hour after the latest training session (the sixth or eighth day of each woman's menstural cycle). Method of measurement: Using Enzymatic method. The University of Tbriz Approved 2018-08-27 Ethics committee of Tabriz University of Medical Sciences No. A3, Shahid Beheshti Street, Gharebaghiha Ave, second floor of Nour Tower Tabriz East Azarbaijan Iran (Islamic Republic of)