The effect of high intensity interval training with spirulina supplementation on cardiovascular metabolic risk factors and body composition of obese elderly women.
The purpose of this study is to investigate the protective effect of high intensity interval training with spirulina supplement on cardiovascular metabolic risk factors of obese elderly women.
Design
A clinical trial with a control group, with parallel groups ( supplement plus training, placebo plus training, supplement and control), double-blind on 40 elderly people. A table of random numbers was used for randomization.
Settings and conduct
After selecting 40 obese elderly women who meet the conditions to enter and refer to the health centers of Birjand city and grouping people, for eight weeks, training groups have three exercise sessions with an intensity of 65 to 75% of the reserve heart rate and spirulina groups will also follow the daily intake of 1000 mg of the supplement. For double-blinding, before the start of the research, the packages containing the supplement and placebo will be marked by a person other than the researcher, and the consumption of the supplement and placebo will be done under the supervision of the same person.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range is 60-75 years
BMI more than 25 kg/m2
Having general physical and mental health
Inactive lifestyle
Exclusion criteria:
Using aids for walking
Using the drug in the previous 6 months
Having cardiovascular diseases
Intervention groups
Intervention group 1: training with spirulina, two 500 mg spirulina capsules daily and high intensity interval training 3 times a week
Intervention group 2: spirulina, two 500 mg spirulina capsules daily
Intervention group 3: training with placebo, two placebo capsules of 500 mg daily and high intensity interval training 3 times a week
Control group: following daily activities without taking supplements and training
Main outcome variables
Angiopoietin-like factor-4, lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220322054338N1
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2024-02-07, 1402/11/18
Update count:0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
elham ghasemi
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3123 2080
Email address
elhamghasemi@uoz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high intensity interval training with spirulina supplementation on cardiovascular metabolic risk factors and body composition of obese elderly women.
Public title
The effect of high intensity interval training and spirulina supplementation on cardiovascular metabolic risk factors and body composition of obese elderly women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range is 60-75 years
BMI more than 25 kg/m2
Inactive lifestyle (exercise activity less than 1 hour per week)
Having general physical and mental health
Exclusion criteria:
Using aids for walking
Using the drug in the previous 6 months
Having chronic diseases, especially cardiovascular diseases
Age
From 60 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 40 elderly women volunteers eligible to participate in the study by non-probability sampling method (easy and accessible) and based on the purpose of selection and then randomly divided into four equal groups of supplement plus training, placebo plus training, supplement and control. A table of random numbers will be used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the supplement consuming groups will receive 2 capsules of 500 mg of spirulina in 2 times in the morning and in the evening for eight weeks (1000 mg of spirulina supplement per day), while in the placebo groups, 2 capsules containing starch will be taken daily. Before the start of the research, the cans with supplements and placebo will be marked by a person other than the researcher so that the researcher and participants are not informed about the type of capsules received. Supplement and placebo were taken under the supervision of the same person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sport Sciences Research Institute