Blood PressureNCT06600243

Influence of Microfiltered-seawater Supplementation and Variable Resistance Training in Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women

A study testing Resistance training + deep sea water in people with Blood Pressure and Oxidative Stress, run by University of Valencia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women. Read more about this study

Who is it for?: Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Blood Pressure, Oxidative Stress, Renal Disease
What is being tested?: Resistance training + deep sea water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: No sites listed yet
Study dates: May 2014to Jul 2015
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 65 years and older
Women only
Healthy volunteers accepted
Older adult

Who may be able to join

(i) women aged ≥65years
(ii) able to climb 10 stairs without pause and walk 100m without a walker
(iii) score above 23 points in the mini-mental state examination
(iv) <1h of physical activity per week throughout the six months before the study
(v) possess a medical certificate of aptitude to carry out physical activity

Who cannot join

Participants who had suffered:
(i) any type of musculoskeletal, cardiovascular, hepatic, renal, pulmonary, neurological, or neuromuscular injury or disorder and/or
(ii) taking any type of drug/supplement that may alter the results of the study (e.g., vitamin C, vitamin E, estrogens, beta-blockers, calcitonin, steroid hormones, etc.)
(iii) changes in body weight of more than 10% in the year prior to the study
(iv) have a severe hearing or visual impairment
(v) participate in another research project (within the last six months) involving an exercise, dietetic and/or pharmaceutical intervention

About this study

Official title: Could Microfiltered-seawater Supplementation and Variable Resistance Training Improve Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women? a 32-week, Double-blinded, Randomized, Placebo-controlled Trial

This study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women.

Read the detailed description

This study was a 32 weeks, double-blinded, randomized, placebo-controlled trial.

Conditions: Blood Pressure, Oxidative Stress, Renal Disease, Hepatic Impairment
Being tested: Resistance training + deep sea water, Resistance training + Placebo, Control + deep sea water, Control + Placebo
Keywords: aged, postmenopause, bone mineral density, muscle strength
Medical subject headings: Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Resistance training + deep sea waterDietary supplement
A group that will perform a resistance training protocol with variable resistance and at the same time will receive a supplementation composed by deep sea water
Resistance training + PlaceboDietary supplement
A group that will perform a resistance training protocol with variable resistance and at the same time will receive a placebo supplementation that have the same tasted than the deep sea water supplementation
Control + deep sea waterDietary supplement
A group that will maintain their usual live and at the same time will receive a supplementation composed by deep sea water
Control + PlaceboDietary supplement
A group that will maintain their usual live and at the same time will receive a placebo supplementation that have the same tasted than the deep sea water supplementation

Study groups in NCT06600243
Study group	Role	What they receive
Resistance training + deep sea water	Experimental	Resistance training with elastic bands prior intake of deep sea water (20ml) twice weekly during 32 weeks. Receives: Dietary Supplement: Resistance training + deep sea water
Resistance training + Placebo	Active comparator	Resistance training with elastic bands prior placebo water (20ml) twice weekly during 32 weeks. Receives: Dietary Supplement: Resistance training + Placebo
Control + Deep sea water	Active comparator	No exercise and intake of deep sea water (20ml) twice weekly during 32 weeks. Receives: Dietary Supplement: Control + deep sea water
Control + Placebo	Placebo comparator	No exercise and intake of placebo water (20ml) twice weekly during 32 weeks. Receives: Dietary Supplement: Control + Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Malondialdehyde (MDA)
Oxidative stress biomarker
Measured: pre (week 0) and post (week 32)
Oxidized/reduced glutathione ratio (GSH/GSSG)
Antioxidant enzyme
Measured: pre (week 0) and post (week 32)
Interleukin-6 (IL-6)
Inflammatory biomarker
Measured: pre (week 0) and post (week 32)
Vitamin D
Vitamin
Measured: pre (week 0) and post (week 32)

Secondary outcomes (12)

Glutamic-oxaloacetic transaminase (GOT)
Hepatic biomarker
Measured: pre (week 0) and post (week 32)
Glutamic-pyruvic transaminase (GPT)
Hepatic biomarker
Measured: pre (week 0) and post (week 32)
Gamma- glutamyl transpeptidase (GGT)
Hepatic biomarker
Measured: pre (week 0) and post (week 32)
Alkaline phosphatase enzyme (ALP)
Hepatic biomarker
Measured: pre (week 0) and post (week 32)
Systolic blood pressure (SBP)
Cardiovascular measure
Measured: pre (week 0) and post (week 32)
Diastolic blood pressure (SBP)
Cardiovascular measure
Measured: pre (week 0) and post (week 32)
Up and Go test (UGT)
Functional test
Measured: pre (week 0) and post (week 32)
Age
Sample demographic description
Measured: pre (week 0) and post (week 32)
Height
Sample demographic description
Measured: pre (week 0) and post (week 32)
Weight
Sample demographic description
Measured: pre (week 0) and post (week 32)
Body mass index (BMI)
Sample demographic description
Measured: pre (week 0) and post (week 32)
Fat mass percentage (% fat mass)
Sample demographic description
Measured: pre (week 0) and post (week 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jul 2015

First posted19 Sep 2024
Study startMay 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by University of ValenciaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06600243
Sponsor's protocol ID: H1414072784009
Status last verified: Sep 2024
First submitted: 12 Sep 2024
Last updated: 23 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Could Microfiltered-seawater Supplementation and Variable Resistance Training Improve Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women? a 32-week, Double-blinded, Randomized, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT06600243
Acronym / sponsor ID: H1414072784009
Conditions: Blood Pressure, Oxidative Stress, Renal Disease, Hepatic Impairment
Keywords: aged, postmenopause, bone mineral density, muscle strength
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: University of ValenciaUniversity, hospital or other
Study start: May 2014 (actual)
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 19 Sep 2024 (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.

This study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women.

Detailed description

This study was a 32 weeks, double-blinded, randomized, placebo-controlled trial.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Resistance training + deep sea water	Experimental	Dietary Supplement: Resistance training + deep sea waterResistance training with elastic bands prior intake of deep sea water (20ml) twice weekly during 32 weeks.
Resistance training + Placebo	Active comparator	Dietary Supplement: Resistance training + PlaceboResistance training with elastic bands prior placebo water (20ml) twice weekly during 32 weeks.
Control + Deep sea water	Active comparator	Dietary Supplement: Control + deep sea waterNo exercise and intake of deep sea water (20ml) twice weekly during 32 weeks.
Control + Placebo	Placebo comparator	Dietary Supplement: Control + PlaceboNo exercise and intake of placebo water (20ml) twice weekly during 32 weeks.

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

(i) women aged ≥65years
(ii) able to climb 10 stairs without pause and walk 100m without a walker
(iii) score above 23 points in the mini-mental state examination
(iv) <1h of physical activity per week throughout the six months before the study
(v) possess a medical certificate of aptitude to carry out physical activity

Key exclusion criteria (6 listed)

(i) any type of musculoskeletal, cardiovascular, hepatic, renal, pulmonary, neurological, or neuromuscular injury or disorder and/or
(ii) taking any type of drug/supplement that may alter the results of the study (e.g., vitamin C, vitamin E, estrogens, beta-blockers, calcitonin, steroid hormones, etc.)
(iii) changes in body weight of more than 10% in the year prior to the study
(iv) have a severe hearing or visual impairment
(v) participate in another research project (within the last six months) involving an exercise, dietetic and/or pharmaceutical intervention

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
Resistance training + deep sea waterA group that will perform a resistance training protocol with variable resistance and at the same time will receive a supplementation composed by deep sea water	Dietary supplement	Resistance training + deep sea water
Resistance training + PlaceboA group that will perform a resistance training protocol with variable resistance and at the same time will receive a placebo supplementation that have the same tasted than the deep sea water supplementation	Dietary supplement	Resistance training + Placebo
Control + deep sea waterA group that will maintain their usual live and at the same time will receive a supplementation composed by deep sea water	Dietary supplement	Control + Deep sea water
Control + PlaceboA group that will maintain their usual live and at the same time will receive a placebo supplementation that have the same tasted than the deep sea water supplementation	Dietary supplement	Control + Placebo

Primary outcome

Malondialdehyde (MDA)
Time frame: pre (week 0) and post (week 32)
Oxidative stress biomarker
Oxidized/reduced glutathione ratio (GSH/GSSG)
Time frame: pre (week 0) and post (week 32)
Antioxidant enzyme
Interleukin-6 (IL-6)
Time frame: pre (week 0) and post (week 32)
Inflammatory biomarker
Vitamin D
Time frame: pre (week 0) and post (week 32)
Vitamin

12 secondary outcomes

Glutamic-oxaloacetic transaminase (GOT)
Time frame: pre (week 0) and post (week 32)
Glutamic-pyruvic transaminase (GPT)
Time frame: pre (week 0) and post (week 32)
Gamma- glutamyl transpeptidase (GGT)
Time frame: pre (week 0) and post (week 32)
Alkaline phosphatase enzyme (ALP)
Time frame: pre (week 0) and post (week 32)
Systolic blood pressure (SBP)
Time frame: pre (week 0) and post (week 32)
Diastolic blood pressure (SBP)
Time frame: pre (week 0) and post (week 32)
Up and Go test (UGT)
Time frame: pre (week 0) and post (week 32)
Age
Time frame: pre (week 0) and post (week 32)
Height
Time frame: pre (week 0) and post (week 32)
Weight
Time frame: pre (week 0) and post (week 32)
Body mass index (BMI)
Time frame: pre (week 0) and post (week 32)
Fat mass percentage (% fat mass)
Time frame: pre (week 0) and post (week 32)

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 23 Sep 2024.

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Chronic Kidney Disease and Hypertension
Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Resistance training + deep sea water in people with Blood Pressure and Oxidative Stress, run by University of Valencia.

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 5 inclusion and 6 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 23 Sep 2024. 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. Some participants in this study may receive a placebo. 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?

Malondialdehyde (MDA) (time frame: pre (week 0) and post (week 32)). The study lists 4 primary outcomes in all. 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 NCT06600243.

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 23 Sep 2024.