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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Hepatic Impairment; Oxidative Stress; Renal Disease
• Intervention / Treatment: Dietary supplement: Resistance training + deep sea water; Dietary supplement: Resistance training + Placebo; Dietary supplement: Control + deep sea water; Dietary supplement: Control + Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance training + deep sea water; Resistance training with elastic bands prior intake of deep sea water (20ml) twice weekly during 32 weeks.	Dietary supplement: 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
Active Comparator: Resistance training + Placebo; Resistance training with elastic bands prior placebo water (20ml) twice weekly during 32 weeks.	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
Active Comparator: Control + Deep sea water; No exercise and intake of deep sea water (20ml) twice weekly during 32 weeks.	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
Placebo Comparator: Control + Placebo; No exercise and intake of placebo water (20ml) twice weekly during 32 weeks.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: muscle strength; aged; postmenopause; bone mineral density
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: H1414072784009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No