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Completed

NCT Number: NCT06600243

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

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.

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Key information

Conditions

Blood Pressure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatic Impairment Kidney Diseases Male Urogenital Diseases Oxidative Stress Renal Disease Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training + deep sea water

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

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

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

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

Primary outcomes

  1. Malondialdehyde (MDA)

    Time frame: pre (week 0) and post (week 32)

    Oxidative stress biomarker

  2. Oxidized/reduced glutathione ratio (GSH/GSSG)

    Time frame: pre (week 0) and post (week 32)

    Antioxidant enzyme

  3. Interleukin-6 (IL-6)

    Time frame: pre (week 0) and post (week 32)

    Inflammatory biomarker

  4. Vitamin D

    Time frame: pre (week 0) and post (week 32)

    Vitamin

Secondary outcomes

  1. Glutamic-oxaloacetic transaminase (GOT)

    Time frame: pre (week 0) and post (week 32)

    Hepatic biomarker

  2. Glutamic-pyruvic transaminase (GPT)

    Time frame: pre (week 0) and post (week 32)

    Hepatic biomarker

  3. Gamma- glutamyl transpeptidase (GGT)

    Time frame: pre (week 0) and post (week 32)

    Hepatic biomarker

  4. Alkaline phosphatase enzyme (ALP)

    Time frame: pre (week 0) and post (week 32)

    Hepatic biomarker

  5. Systolic blood pressure (SBP)

    Time frame: pre (week 0) and post (week 32)

    Cardiovascular measure

  6. Diastolic blood pressure (SBP)

    Time frame: pre (week 0) and post (week 32)

    Cardiovascular measure

  7. Up and Go test (UGT)

    Time frame: pre (week 0) and post (week 32)

    Functional test

  8. Age

    Time frame: pre (week 0) and post (week 32)

    Sample demographic description

  9. Height

    Time frame: pre (week 0) and post (week 32)

    Sample demographic description

  10. Weight

    Time frame: pre (week 0) and post (week 32)

    Sample demographic description

  11. Body mass index (BMI)

    Time frame: pre (week 0) and post (week 32)

    Sample demographic description

  12. Fat mass percentage (% fat mass)

    Time frame: pre (week 0) and post (week 32)

    Sample demographic description

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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