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

NCT06600243 | Completed

• 1 other identifier: H1414072784009
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Blood Pressure; Oxidative Stress; Renal Disease; Hepatic Impairment

Keywords

aged; postmenopause; bone mineral density; muscle strength

Outcome Measures

Primary Outcomes (4)

• Malondialdehyde (MDA)

  Oxidative stress biomarker

  pre (week 0) and post (week 32)

• Oxidized/reduced glutathione ratio (GSH/GSSG)

  Antioxidant enzyme

  pre (week 0) and post (week 32)

• Interleukin-6 (IL-6)

  Inflammatory biomarker

  pre (week 0) and post (week 32)

• Vitamin D

  Vitamin

  pre (week 0) and post (week 32)

Secondary Outcomes (12)

• Glutamic-oxaloacetic transaminase (GOT)

  pre (week 0) and post (week 32)

• Glutamic-pyruvic transaminase (GPT)

  pre (week 0) and post (week 32)

• Gamma- glutamyl transpeptidase (GGT)

  pre (week 0) and post (week 32)

• Alkaline phosphatase enzyme (ALP)

  pre (week 0) and post (week 32)

• Systolic blood pressure (SBP)

  pre (week 0) and post (week 32)

Study Arms (4)

Resistance training + deep sea water

EXPERIMENTAL

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

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.

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.

Dietary Supplement: Control + deep sea water

Control + Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Control + Placebo

Interventions

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 + 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

Resistance training + Placebo

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 + 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

Control + Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

MeSH Terms

Conditions

Kidney Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 23, 2024

Record last verified: 2024-09