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

NCT ID: NCT06600243

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-07-31

Brief Summary

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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

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

Conditions

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Blood Pressure Oxidative Stress Renal Disease Hepatic Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Resistance training + deep sea water

Resistance training with elastic bands prior intake of deep sea water (20ml) twice weekly during 32 weeks.

Group Type EXPERIMENTAL

Resistance training + deep sea water

Intervention Type DIETARY_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 + Placebo

Resistance training with elastic bands prior placebo water (20ml) twice weekly during 32 weeks.

Group Type ACTIVE_COMPARATOR

Resistance training + Placebo

Intervention Type DIETARY_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 water

No exercise and intake of deep sea water (20ml) twice weekly during 32 weeks.

Group Type ACTIVE_COMPARATOR

Control + deep sea water

Intervention Type DIETARY_SUPPLEMENT

A group that will maintain their usual live and at the same time will receive a supplementation composed by deep sea water

Control + Placebo

No exercise and intake of placebo water (20ml) twice weekly during 32 weeks.

Group Type PLACEBO_COMPARATOR

Control + Placebo

Intervention Type DIETARY_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

Interventions

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Resistance training + deep sea water

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

Intervention Type DIETARY_SUPPLEMENT

Resistance training + Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Control + deep sea water

A group that will maintain their usual live and at the same time will receive a supplementation composed by deep sea water

Intervention Type DIETARY_SUPPLEMENT

Control + Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* (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

Exclusion Criteria

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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Juan C. Colado

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H1414072784009

Identifier Type: -

Identifier Source: org_study_id

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