Clinical trial NCT06600243: Influence of Microfiltered-seawater Supplementation and Variable Resistance Training in Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Oxidative Stress
Renal Disease
Hepatic Impairment
Keywords: aged
postmenopause
bone mineral density
muscle strength
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 109
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Malondialdehyde (MDA)
timeFrame: pre (week 0) and post (week 32)
measure: Oxidized/reduced glutathione ratio (GSH/GSSG)
timeFrame: pre (week 0) and post (week 32)
measure: Interleukin-6 (IL-6)
timeFrame: pre (week 0) and post (week 32)
measure: Vitamin D
timeFrame: pre (week 0) and post (week 32)
Secondary outcomes:
measure: Glutamic-oxaloacetic transaminase (GOT)
timeFrame: pre (week 0) and post (week 32)
measure: Glutamic-pyruvic transaminase (GPT)
timeFrame: pre (week 0) and post (week 32)
measure: Gamma- glutamyl transpeptidase (GGT)
timeFrame: pre (week 0) and post (week 32)
measure: Alkaline phosphatase enzyme (ALP)
timeFrame: pre (week 0) and post (week 32)
measure: Systolic blood pressure (SBP)
timeFrame: pre (week 0) and post (week 32)
measure: Diastolic blood pressure (SBP)
timeFrame: pre (week 0) and post (week 32)
measure: Up and Go test (UGT)
timeFrame: pre (week 0) and post (week 32)
measure: Age
timeFrame: pre (week 0) and post (week 32)
measure: Height
timeFrame: pre (week 0) and post (week 32)
measure: Weight
timeFrame: pre (week 0) and post (week 32)
measure: Body mass index (BMI)
timeFrame: pre (week 0) and post (week 32)
measure: Fat mass percentage (% fat mass)
timeFrame: pre (week 0) and post (week 32)
Other outcomes:
Locations:
Study officials:
References: