Protocol summary
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Study aim
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The aim of the present study is to investigate the effect of chlorella vulgaris algae supplementation, HIIT exercises and their combination on the serum levels of PGC-1α, FGF21, SIRT1, nutritional status, body composition and aerobic power in young women with overweight and obesity.
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Design
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Randomized clinical trial, double blinded with four parallel groups
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Settings and conduct
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The intervention will be conducted at gym of the University of Medical Sciences and Faculty of Physical Education of Tabriz University for 8 weeks. Supplements and placebo will be coded by the person in charge, and the main investigators and patients will be blind to the type of supplement used.
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Participants/Inclusion and exclusion criteria
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44 participants with BMI between 25 and 34.9 will be included in the study. Individual consent and inclination to cooperation is an inclusion criteria Bone and joint problems will not be included.
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Intervention groups
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Intervention group 1: Supplementation of Chlorella Vulgaris from the Green Iranian's future Company (900 mg / day, 300 mg) and HIIT performance (three sessions per week for 60 minutes).
Intervention group 2: HIIT performance (similar protocol) exercises and receive the placebo from Iranian's Green future.
Intervention group 3: Receive chlorella vulgaris (900 mg / day, 300 mg).
Control group: Will receive the same placebo with the same protocol.
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Main outcome variables
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Time to get tired with Bruce test; Maximum oxygen consumption; Aerobic power ; Anthropometric indices and body composition (FM, FFM, BW); Basal Metabolic Rate (BMR); Blood pressure; Heart rate; Food intake (energy, carbohydrate, protein and fat). ); Physical activity; fasting blood glucose, lipid profile (TC, HDL-C, TG, LDL-C), serum level of Sirtuin1(SIRT-1), Fibroblast Growth Factor 21 (FGF21) and Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α).
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190224042821N1
Registration date:
2019-03-09, 1397/12/18
Registration timing:
prospective
Last update:
2021-10-29, 1400/08/07
Update count:
1
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Registration date
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2019-03-09, 1397/12/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-21, 1398/02/01
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Expected recruitment end date
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2019-06-22, 1398/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of chlorella vulgaris algae supplementation, HIIT exercises and their combination on the serum levels of PGC-1α, FGF21, SIRT1, nutritional status, body composition and aerobic power in young women with overweight and obesity
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Public title
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Effect of chlorella vulgaris algae and HIIT exercises on overweight and obesity
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Tendency and the ability of cooperation
The age range of 18 to 35
BMI in the range of overweight to type 1 obesity (25-34.9)
Exclusion criteria:
Joint and bone disease
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Selection would be simple allocation with blocking.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (chlorella vulgaris or placebo) received by each group. The person responsible for preparing the supplement boxes(who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (chlorella vulgaris and placebo), and keep the codes for himself until the end of the study and data analyses.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-05, 1397/11/16
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Ethics committee reference number
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IR.TBZMED.REC.1397.922
Health conditions studied
1
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Description of health condition studied
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Overweight and obesity
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ICD-10 code
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E66.9
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ICD-10 code description
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Obesity, unspecified
Primary outcomes
1
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Description
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Time to reach the fatigue
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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The time to reach the fatigue or maximum power of a person is done using the Bruce test with the help of treadmill. The test results are reported in minutes and indicate the cardiovascular power.
2
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Description
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VO2 maximum or aerobic power
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Maximum oxygen consumption (VO2max) or maximum aerobic power is the highest oxygen content used in extreme exercise and is the most important aerobic fitness index, cardiovascular health and endurance ability. VO2max can be measured by direct and indirect methods. Here using the indirect method, the Bruce test on the treadmill, which measures the VO2max from the time of performance or the maximum power output.
3
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Description
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Anthropometric measures
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumferences by a tape measure. Calculation of waist to hip ratio (WHR) by dividing waist circumference by hip circumference, and body mass index (BMI) by dividing weight (Kg) by height squared (m2).
4
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Description
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Body composition
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW)
5
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Description
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Resting metabolic rate
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Indirect calorimetry
6
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Description
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Blood pressure
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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It is done using a medical barometer.
7
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Description
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Heart rate
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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It is done using a digital barometer.
8
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Description
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Blood glucose
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Enzymatic method
9
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Description
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Lipid profile
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation
10
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Description
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Blood insulin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
11
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Description
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Insulin resistance
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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By the use of formula
12
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Description
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SIRT1
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
13
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Description
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FGF21
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
14
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Description
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PGC-1alpha
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
15
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Description
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Serum Irisin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
16
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group 1: Participants will receive daily chlorella vulgaris supplement provided by the Iranian's Green Future company (900 mg/day in 300 mg pills after three main meals) and HIIT exercises (three sessions per week for 60 minutes) for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Participants will perform HIIT exercises (three sessions per week for 60 minutes) and they will receive a placebo similar to the supplement provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks.
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Category
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Treatment - Other
3
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Description
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Intervention group 3: : Participants will receive daily Chlorella Vulgaris supplement provided by the Iranian's Green future Company (900 mg/day in 300 mg pills after three main meals) for 8 weeks
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Category
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Treatment - Drugs
4
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Description
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Control group:Receive the same placebo with supplements provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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access starting 12 months after publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
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From where data/document is obtainable
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To access the required data, the researchers can contact Ms. Mahzad Sanayei: email address: mahzad.sanayei@gmail.com cellphone number: 0098 9132210641
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What processes are involved for a request to access data/document
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The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.
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Comments
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