Stress OxidativeMDANCT04226183
Natural Antioxidant Intake After Exercise Can Oxidative Stress in the Third Trimester of Pragnancy
A study testing pregnancy workout in people with Stress Oxidative, run by Universitas Indonesia.
Trial summary
Pregnancy is a condition that increased requirements of energy and oxygen, and if this condition is not maximally that can lead oxidative stress and produce free radicals which is affect in the pregnancy process. Malondialdehyde (MDA) level in pregnant women is higher than non-pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Oxidative
- What is being tested?
- pregnancy workout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2016to 17 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Approve as a subject of review and sign in an informed consent
- Approve to take 3 ml of whole blood.
- Ages 20-30 years
- Hemoglobin levels higher than 11 gr%
- Third trimester of pregnancy
- Healthy condition during reseach
Who cannot join
- Anemia
- Pathologies condition during pregnant
- Allergic
- Disability
About this study
Official title: Natural Antioxidant Intake After Exercise Can Reduce Malondialdehyde (MDA) Level in the Third Trimester of Pragnancy
Pregnancy is a condition that increased requirements of energy and oxygen, and if this condition is not maximally that can lead oxidative stress and produce free radicals which is affect in the pregnancy process. Malondialdehyde (MDA) level in pregnant women is higher than non-pregnant women. Exercise is one way to neutralize the free radical. The aim of this study was analyzed effect of treatment natural antioxidants after exercise which was pregnancy workout to MDA level in the third trimester of pregnancy.
This study was a true experimental study. There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without pregnancy workout as a control group, 8 prenatal pregnant women with pregnancy workout but without natural antioxidant consume as a positive control group, and 8 prenatal pregnant women with natural antioxidant consume after pregnancy workout as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C. MDA levels was analyzed by spectrophotometric. Comparison between groups was done by one way ANOVA test.
Read the detailed description
Pregnancy is a condition that is vulnerable to all kinds - stress resulting in changes in physiology and metabolic function. In pregnancy there is also an increase in energy and oxygen requirements.
The metabolic process can increase require of the oxygen and if it is not available as well as unmaximal used can causes the formation of oxidative stress and produces excessive free radicals which ultimately, that affected in the saferity of a pregnancy process. The imbalance between antioxidants and free radicals in pregnancy prosses are causes pathological and complications changes in pregnancy. This kind of biochemical marker of antioxidants and oxidants is very useful in observing complications that may arise in pregnancy.
Treatment given is expected to eliminate complaints that arise while exercise during pregnancy can prevent the formation of free radicals, but exercise must be given in accordance with the ability of pregnant women.
Physical exercise or exercise in pregnancy can maintain excess weight gain, prevent diabetes, hypertension, and shorten labor time. Sports is one way to neutralize the formation of free radicals because by doing physical activity, excessive oxygen can be used to produce energy.
Increased free radicals are characterised by an increase of malondialdehyde (MDA) as a biochemical markers. Malondialdehyde (MDA) which is the output of lipid peroxidation prosses that measured to determine the presence of oxidative stress due to damage by free radicals. The resent study was found that MDA levels in pregnant women were higher compared to non-pregnant women. Increased MDA levels are in line with the increase in gestational age, from the first, second, and third trimesters. Study was also found that there was a significant increase in MDA levels accompanied by a decrease in non-enzymatic antioxidants, such as Vitamin-E, Vitamin-C, and Vitamin-A in pregnant women with hypertension. Moreover this study assums that was "Giving Antioxidant to decrease Malondialdehyde (MDA) in the third trimester of pregnancy". futher more the aims of this study was analyzed effect of natural antioxidants treatment after exercise to MDA level in the third trimester of pregnancy.
This study was a experimental study. This study was located in the several clinics midwife practice, Community Health Centers (Puskesmas) in Palembang and Bio Sains Riset Laboratory Palembang from August to October 2016.
the study was approved informed consent from all participans as well as ethical clearance approval number is 007/UP-ETIK/I/2016. This study was obtained 24 prenatal pregnant women that separated to 3 groups, which were 8 prenatal pregnant women without pregnancy workout exercise as a control group, 8 prenatal pregnant women with pregnancy workout exercise as a positive control group and 8 prenatal pregnant women with consume natural antioxidants after pregnancy workout exercise as a treatment group.
The antioxidant compounds given in this study were natural vitamin C from 100 ml guava juice without additionaly sugar, 5 cc syringe, cotton, alcohol, syringe, hanscoon, EDTA tube, serum, TCA 5%, Na thiobarbiturat 0,65%, MDA standart, and aquades.
Spectrophotometric assay used to measure the MDA levels in the Bio Sains Riset Laboratory, Palembang and followed the essay of protocol kit from manufacture.
Comparison between groups used by one way ANOVA test, that was considered significant if p < 0.05. All statistical analyses were done by SPPS for Windows version 16.0.
- Conditions
- Stress Oxidative
- Being tested
- pregnancy workout
- Keywords
- Antioxidants, Malondialdehyde level, the third trimester of pregnancy, exercise, anti oxidant, stress oxidative
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnancy workoutOther
Also called fresh Guava juice
Procedure of pregnancy workout has been legalized by the Ministry of Health of Indonesia act 2014 No.97.
100 ml fresh guava juice without sugar
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | pregnant women without pregnancy workout and consume guava juice |
| positive control group | Experimental | prenatal pregnant women with pregnancy workout but not consume guava juice Receives: Other: pregnancy workout |
| treatment group | Experimental | prenatal pregnant women with pregnancy workout and consume guava juice Receives: Other: pregnancy workout |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDA level
Malondialdehyde (MDA) levels is stress oxidative marker. MDA level messured with spectrophotometric assay. at Bio Sains Riset Laboratory, Palembang. Firstly, Mix 0.5ml blank + 0.5 ml standard and 0.5 ml serum using vortex mixer. Centrifuge for 10 minutes, with a speed of 2000 rpm, and Pipette 1 ml each filtrate and after that put it in boiling water bath for 30 minutes, then chill and read the absorbance with a spectrophotometer with a wavelength of 550 nm.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Feb 2016
- Primary completion26 Aug 2016
- Study completion17 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress OxidativeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without exercise as a control group, 8 prenatal pregnant women with exercise as a positive control group and 8 prenatal pregnant women with exercise and consume natural antioxidants after exercise as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH
- Responsible party
- Principal investigator, Dr. Ocktariyana, SST, M.Kes, Universitas Indonesia
- Investigators
- Ocktariyana Ocktariyana, Principal investigator, Ministry of health, Health Polytechnic, Palembang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226183
- Sponsor's protocol ID
- qwery123
- Acronym
- MDA
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nazari A, Dirandeh E, Ansari-Pirsaraei Z, Deldar H. Antioxidant levels, copper and zinc concentrations were associated with postpartum luteal activity, pregnancy loss and pregnancy status in Holstein dairy cows. Theriogenology. 2019 Jul 15;133:97-103. doi: 10.1016/j.theriogenology.2019.04.034. Epub 2019 Apr 30.
PubMed 31078069Patil SB, Kodliwadmath MV, Kodliwadmath SM. Correlation between lipid peroxidation and non-enzymatic antioxidants in pregnancy induced hypertension. Indian J Clin Biochem. 2008 Jan;23(1):45-8. doi: 10.1007/s12291-008-0011-9. Epub 2008 Mar 6.
PubMed 23105719
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Antioxidant Intake After Exercise Can Reduce Malondialdehyde (MDA) Level in the Third Trimester of Pragnancy
- ClinicalTrials.gov ID
- NCT04226183
- Acronym / sponsor ID
- MDA / qwery123
- Conditions
- Stress Oxidative
- Keywords
- Antioxidants, Malondialdehyde level, the third trimester of pregnancy, exercise, anti oxidant, stress oxidative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Indonesia-MoH
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 17 Oct 2016 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy is a condition that increased requirements of energy and oxygen, and if this condition is not maximally that can lead oxidative stress and produce free radicals which is affect in the pregnancy process. Malondialdehyde (MDA) level in pregnant women is higher than non-pregnant women. Exercise is one way to neutralize the free radical. The aim of this study was analyzed effect of treatment natural antioxidants after exercise which was pregnancy workout to MDA level in the third trimester of pregnancy.
This study was a true experimental study. There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without pregnancy workout as a control group, 8 prenatal pregnant women with pregnancy workout but without natural antioxidant consume as a positive control group, and 8 prenatal pregnant women with natural antioxidant consume after pregnancy workout as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C. MDA levels was analyzed by spectrophotometric. Comparison between groups was done by one way ANOVA test.
Detailed description
Pregnancy is a condition that is vulnerable to all kinds - stress resulting in changes in physiology and metabolic function. In pregnancy there is also an increase in energy and oxygen requirements.
The metabolic process can increase require of the oxygen and if it is not available as well as unmaximal used can causes the formation of oxidative stress and produces excessive free radicals which ultimately, that affected in the saferity of a pregnancy process. The imbalance between antioxidants and free radicals in pregnancy prosses are causes pathological and complications changes in pregnancy. This kind of biochemical marker of antioxidants and oxidants is very useful in observing complications that may arise in pregnancy.
Treatment given is expected to eliminate complaints that arise while exercise during pregnancy can prevent the formation of free radicals, but exercise must be given in accordance with the ability of pregnant women.
Physical exercise or exercise in pregnancy can maintain excess weight gain, prevent diabetes, hypertension, and shorten labor time. Sports is one way to neutralize the formation of free radicals because by doing physical activity, excessive oxygen can be used to produce energy.
Increased free radicals are characterised by an increase of malondialdehyde (MDA) as a biochemical markers. Malondialdehyde (MDA) which is the output of lipid peroxidation prosses that measured to determine the presence of oxidative stress due to damage by free radicals. The resent study was found that MDA levels in pregnant women were higher compared to non-pregnant women. Increased MDA levels are in line with the increase in gestational age, from the first, second, and third trimesters. Study was also found that there was a significant increase in MDA levels accompanied by a decrease in non-enzymatic antioxidants, such as Vitamin-E, Vitamin-C, and Vitamin-A in pregnant women with hypertension. Moreover this study assums that was "Giving Antioxidant to decrease Malondialdehyde (MDA) in the third trimester of pregnancy". futher more the aims of this study was analyzed effect of natural antioxidants treatment after exercise to MDA level in the third trimester of pregnancy.
This study was a experimental study. This study was located in the several clinics midwife practice, Community Health Centers (Puskesmas) in Palembang and Bio Sains Riset Laboratory Palembang from August to October 2016.
the study was approved informed consent from all participans as well as ethical clearance approval number is 007/UP-ETIK/I/2016. This study was obtained 24 prenatal pregnant women that separated to 3 groups, which were 8 prenatal pregnant women without pregnancy workout exercise as a control group, 8 prenatal pregnant women with pregnancy workout exercise as a positive control group and 8 prenatal pregnant women with consume natural antioxidants after pregnancy workout exercise as a treatment group.
The antioxidant compounds given in this study were natural vitamin C from 100 ml guava juice without additionaly sugar, 5 cc syringe, cotton, alcohol, syringe, hanscoon, EDTA tube, serum, TCA 5%, Na thiobarbiturat 0,65%, MDA standart, and aquades.
Spectrophotometric assay used to measure the MDA levels in the Bio Sains Riset Laboratory, Palembang and followed the essay of protocol kit from manufacture.
Comparison between groups used by one way ANOVA test, that was considered significant if p < 0.05. All statistical analyses were done by SPPS for Windows version 16.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without exercise as a control group, 8 prenatal pregnant women with exercise as a positive control group and 8 prenatal pregnant women with exercise and consume natural antioxidants after exercise as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –pregnant women without pregnancy workout and consume guava juice |
| positive control group | Experimental | Other: pregnancy workoutprenatal pregnant women with pregnancy workout but not consume guava juice |
| treatment group | Experimental | Other: pregnancy workoutprenatal pregnant women with pregnancy workout and consume guava juice |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Approve as a subject of review and sign in an informed consent
- Approve to take 3 ml of whole blood.
- Ages 20-30 years
- Hemoglobin levels higher than 11 gr%
- Third trimester of pregnancy
Key exclusion criteria (4 listed)
- Anemia
- Pathologies condition during pregnant
- Allergic
- Disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregnancy workoutAlso: fresh Guava juiceProcedure of pregnancy workout has been legalized by the Ministry of Health of Indonesia act 2014 No.97. 100 ml fresh guava juice without sugar | Other | positive control group, treatment group |
Primary outcome
MDA level
Time frame: 7 days.
Malondialdehyde (MDA) levels is stress oxidative marker. MDA level messured with spectrophotometric assay. at Bio Sains Riset Laboratory, Palembang. Firstly, Mix 0.5ml blank + 0.5 ml standard and 0.5 ml serum using vortex mixer. Centrifuge for 10 minutes, with a speed of 2000 rpm, and Pipette 1 ml each filtrate and after that put it in boiling water bath for 30 minutes, then chill and read the absorbance with a spectrophotometer with a wavelength of 550 nm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Results publication: PubMed 31078069Nazari A, Dirandeh E, Ansari-Pirsaraei Z, Deldar H. Antioxidant levels, copper and zinc concentrations were associated with postpartum luteal activity, pregnancy loss and pregnancy status in Holstein dairy cows. Theriogenology. 2019 Jul 15;133:97-103. doi: 10.1016/j.theriogenology.2019.04.034. Epub 2019 Apr 30.
- Results publication: PubMed 23105719Patil SB, Kodliwadmath MV, Kodliwadmath SM. Correlation between lipid peroxidation and non-enzymatic antioxidants in pregnancy induced hypertension. Indian J Clin Biochem. 2008 Jan;23(1):45-8. doi: 10.1007/s12291-008-0011-9. Epub 2008 Mar 6.
- Individual participant dataSharing planned: No
Related trials for Stress Oxidative
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ocktariyana Ocktariyana principal investigator
Ministry of health, Health Polytechnic, Palembang
Questions about this trial
What is this clinical trial studying?
A study testing pregnancy workout in people with Stress Oxidative, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDA level (time frame: 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.