The effect of eight weeks of aerobic training and NBS superfood supplement consumption on factors involved in cell death in men undergoing methadone treatment
This study was designed to investigate the combined effect of aerobic exercise, combined with the consumption of the NBS superfood dietary supplement, on cell death factors in men using methadone.
Design
Controlled clinical trial with three non-randomized intervention groups on 60 men using methadone.
Settings and conduct
Male addicts undergoing methadone treatment at Tolo Novin Omid Addiction Treatment Center in Boroujerd will be included in the study if they are eligible and will be assigned to 4 groups. This study is designed as a double-blind study, with both participants and researchers unaware of group assignment (supplement/placebo).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Negative urine test for morphine, cannabis, and methamphetamine, need to use methadone maintenance treatment for at least the past three months, no autoimmune diseases, cardiovascular and pulmonary diseases, no muscle and tendon injuries;
Exclusion criteria:
Unwillingness to participate in the study and being sick
Intervention groups
Intervention group 1: Subjects will perform exercises three times a week for 40 minutes each time for 8 weeks and at the same time, they will receive 4.5 grams of NBS superfood supplement orally in three equal doses daily.
Intervention group 2: Subjects will perform exercises three times a week for 40 minutes each time for 8 weeks and at the same time, they will receive 4.5 grams of potato starch orally in three equal doses daily.
Intervention group 3: Subjects will receive 4.5 grams of NBS superfood supplement orally (soluble in water) daily in three equal doses for 8 weeks.
Control group: Subjects will receive 4.5 grams of placebo (potato starch) orally (soluble in water) daily in three equal doses for 8 weeks.
Main outcome variables
Feroptosis ؛ Oxidative stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141228020465N7
Registration date:2025-06-17, 1404/03/27
Registration timing:retrospective
Last update:2025-06-17, 1404/03/27
Update count:0
Registration date
2025-06-17, 1404/03/27
Registrant information
Name
Fatemeh Omidali
Name of organization / entity
University of Ayatollah Boroujerdi
Country
Iran (Islamic Republic of)
Phone
+98 66 4246 8320
Email address
f.omidali@abru.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-15, 1404/02/25
Expected recruitment end date
2025-06-15, 1404/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of aerobic training and NBS superfood supplement consumption on factors involved in cell death in men undergoing methadone treatment
Public title
The effect of aerobic exercise and superfood supplementation on cell death
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Negative urine test for morphine, cannabis, and methamphetamine.
The need to use methadone maintenance treatment for at least the past three months,
Absence of autoimmune diseases,
absence of cardiovascular and pulmonary diseases
absence of muscle and tendon injuries
Exclusion criteria:
Unwillingness to participate in research
Being sick
Age
From 25 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed as a double-blind study, so that both participants and researchers will be unaware of the group assignment (supplement/placebo). The supplement and placebo will be provided in identical packaging (in terms of appearance, labeling, and method of administration) and distributed by independent staff of the addiction treatment center who are not involved in other parts of the study.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Sports Sciences Research Institute
Street address
Number 3,Fifth Alley -Mir Emad St.-Ostad Motahari St.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-04-20, 1404/01/31
Ethics committee reference number
IR.SSRC.REC.1404.016
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
P04.4
ICD-10 code description
Newborn (suspected to be) affected by maternal use of drugs of addiction
Primary outcomes
1
Description
ferroptosis
Timepoint
Before the intervention and 8 weeks after the end of the intervention
Method of measurement
Blood sample, serum separation, ELISA kit, use of ELISA reader
2
Description
Oxidative stress
Timepoint
Before the intervention and 8 weeks after the end of the intervention
Method of measurement
Blood sample, serum separation, ELISA kit, use of ELISA reader
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Aerobic exercise with supplement intake for 8 weeks. Exercise protocol: First, the subjects will warm up for 10 minutes at an intensity of 50% of maximum heart rate. Aerobic exercise will be performed at an intensity of 75% to 85% of maximum heart rate for 40 minutes, three times a week. Finally, the subjects will cool down for 10 minutes at an intensity of 50% of maximum heart rate. The subjects will receive the NBS Superfood supplement at a rate of 4.5 grams per day orally, dissolved in water, and daily in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey).
Category
Lifestyle
2
Description
Intervention group 2: Aerobic exercise with placebo for 8 weeks. Subjects will first warm up for 10 minutes at an intensity of 50% HRmax. The aerobic exercise groups will perform high-intensity aerobic exercise (75% to 85% HRmax) for 40 minutes each time three times a week. Finally, subjects will cool down for 10 minutes at an intensity of 50% HRmax. The placebo will be 4.5 grams of potato starch orally per day, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening.
Category
Lifestyle
3
Description
Subjects will receive 4.5 grams of NBS Superfood supplement orally, dissolved in water, daily in three equal doses for eight weeks: 1.5 grams in the morning (6 am to 12 pm), 1.5 grams in the afternoon (12 pm to 6 pm) and 1.5 grams in the evening. (from 6 pm to 12 am). The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey).
Category
Lifestyle
4
Description
Control group: The control group will receive only placebo for 8 weeks. They will receive 4.5 grams of potato starch orally, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. They will not do any sports activities and will continue their lifestyle.