Physical Fitness as Klotho Protein Stimulator.

A study testing PAR, HIIT and WB-EMS in people with Physical Activity and Aging, run by Manuel Castillo Garzón.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes). Read more about this study

Who is it for?: Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Physical Activity, Aging
What is being tested?: PAR, HIIT and WB-EMS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: No sites listed yet
Study dates: 1 Jun 2016to 23 Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age: 40-65 years
BMI:18.5-35 kg/m2
Not engaged in regular physical activity >20min on >3days/week
Not participating in a weight loss programme
Stable weight over the last 5 months (body weight changes>5kg)
Participant must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment
Normal electrocardiogram

Who cannot join

History of cardiovascular disease
Diabetes
Pregnancy or planning to get pregnant during study period
Beta blockers or benzodiapezins use
Taking medication for thyroid
Other significant conditions that are life-threatening or that can interfere with or be aggravated by exercise
Unwillingness to either complete the study requirements or to be randomized into control or training group
A first-degree relative with history of cancer

About this study

Official title: Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).

Read the detailed description

Aims: The plasma Klotho protein concentration (α-Klotho protein), which is considered a powerful biomarker of longevity, makes it an attractive target as an anti-aging therapy against functional decline, sarcopenic obesity, metabolic and cardiovascular diseases, osteoporosis, and neurodegenerative disorders. Physical exercise and physical fitness, could be α-Klotho protein activators through biochemical process. FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes).

Methods: FIT-AGING will recruit 60 sedentary, healthy, adults (50% women) aged 40-65 years. Eligible participants will be randomly assigned to a non-exercise group to the usual control group (n=15), physical activity recommendation from American College of Sport Medicine, World Health Organization and American Heart Association group (n=15), High Intensity Interval Training group (n=15)) and Whole-Body Electromyostimulation group (n=15). Laboratory measures completed at baseline and 12 weeks later, include α-Klotho protein concentration, physical fitness (cardiorespiratory fitness, muscular strength), body composition, resting metabolic rate, hearth rate variability (HRV), health blood biomarkers, free-living physical activity, sleep habits reaction time, cognitive variables and health-related questionnaires. The investigators will also obtain dietary habits data and cardiovascular disease risk factors.

Conditions: Physical Activity, Aging
Being tested: PAR, HIIT, WB-EMS
Keywords: Physical fitness, Klotho, Training, HIIT, WB-EMS
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PAROther
HIITOther
WB-EMSOther

Study groups in NCT03334357
Study group	Role	What they receive
Control	No intervention	Non-Exercise group. We will provide general advices to control group participants thought an information meeting performed by a graduate in Sport Sciences. It will recommended to follow the physical activity recommendations for adults provided by World Health Organization
PAR group	Experimental	The volume in PAR is based on the minimum physical activity recommended (150min/week at moderate intensity). Intensity selected for PAR aerobic training is 60-65% HRres. Strength intensity selected was 40-50% of 1 RM. Frequency. PAR group will train 3 days/week, the minimum frequency recommended. Exercises programmed for the aerobic exercise are treadmill, cycle-ergometer and elliptical ergometer in aerobic training part and weight bearing and guided pneumatic machines (involved major upper and lower body muscle group) in resistance training. Training load variation. We propose a gradual progression to control the exercise dose Training periodization divided in two phases of 5 weeks each one, starting with a familiarization phase (2 weeks). Training sessions. Sessions start with a dynamic standardized warm up, which include several muscle activation exercises. Aerobic sessions include compensatory exercises. Training session will be ended with a cooling-down protocol Receives: Other: PAR
HIIT group.	Experimental	The volume in HIIT 40-65 min/week at high intensity. Intensity. Two different protocols: HIIT with long intervals (Type A session), which intensity will be >95% VO2max and HIIT with short intervals (Type B session), >120% VO2max. Training frequency two times/week. Type of exercise. Type A session are walking in treadmill with personalized slopes. Eight weight-bearing exercises in circuit form, type B session. Training load variation. Gradual progression to control the exercise dose. Training periodization divided in: familiarization phase, phase I, phase II. Training sessions. Type A: 5 minutes in treadmill at 60% VO2max. After warm-up, participants complete sets corresponding to each training session following the corresponding characteristics. Type B: eight weight-bearing exercises (in circuit form) two times/set with an active rest (walking at 60%VO2max) as many times at as defined. Training session will be ended with a cooling-down protocol Receives: Other: HIIT
WB-EMS group.	Experimental	WB-EMS training program will be the same than HIIT intervention related to volume, intensity, frequency, type of exercise, training load variation, training periodization and training session. However, electrical impulse will be included in order to assess if WB-EMS training will produce an added effect compared to HIIT. Electrical parameters: We will apply a frequency of 15-33 Hz in type A session. And, we will apply a frequency of 35-75 Hz in type B session. Intensity will be 80-100 mA. Impulse Width adjusted in relation to body segment: thigh zone (400μsec), glute zone (350μsec), abdominal zone (300μsec), dorsal zone (250μsec), cervical (200μsec), chest zone (200μsec) and arm zone (200μsec). Duty cycle. We have programmed a duty cycle of 50-67% in type B session, but duty cycle in type A session will be 99%. RPE impulse: the impulse intensity was individually adapted to generate similar values of rate of perceived exertion (RPE) in Borg CR-10 Scale "5" of "9" Receives: Other: WB-EMS

What is being measured

The primary outcome is the main question the study is designed to answer.

α-Klotho protein
Plasma Klotho concentrations will be measured by ELISA using a soluble α-Klotho ELISA assay kit.
Measured: Baseline and through study completion, an average of 12 weeks.

Secondary outcomes (13)

Physical fitness: cardiorespiratory fitness
Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).
Measured: Baseline and through study completion, an average of 12 weeks.
Physical fitness: muscular strength.
Muscle strength measure through: Isokinetic strength, Handgrip strength and Core resistance stability.
Measured: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
Body composition.
Measure by DXA.
Measured: Baseline and through study completion, an average of 12 weeks.
Resting energy expenditure.
Evaluated by indirect calorimetry with gas analyzer breath by breath.
Measured: Baseline and through study completion, an average of 12 weeks.
Hearth Rate Variability (HRV).
Measure by Polar RS800CX.
Measured: Baseline and through study completion, an average of 12 weeks.
Biochemical profile.
General biochemical profile in blood samples
Measured: Baseline and through study completion, an average of 12 weeks.
Physical activity.
The amount of physical activity will be measured by accelerometer.
Measured: Baseline and through study completion, an average of 12 weeks.
Reaction time.
Measure by Vienna System.
Measured: Baseline and through study completion, an average of 12 weeks.
Cognitive test.
Auditory memory tests
Measured: Baseline and through study completion, an average of 12 weeks.
Dietary assessment.
Measure by 24h recall and Food Frecuency Questionnaire.
Measured: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Anthopometric measures.
Measure by stadiometer and scale.
Measured: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Sleep quality.
The quality of sleep will be measured by accelerometer.
Measured: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Hormones profile
Hormones profile measure in blood samples.
Measured: Baseline and post-Baseline and through study completion, an average of 12 weeks..

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201623 Dec 2017

First posted7 Nov 2017
Study start1 Jun 2016
Primary completion23 Dec 2017
Study completion23 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03334357
Sponsor's protocol ID: FPU14/04172
Acronym: FIT-AGING
Status last verified: Oct 2018
First submitted: 30 Oct 2017
Last updated: 12 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Navarro-Lomas G, Dote-Montero M, Alcantara JMA, Plaza-Florido A, Castillo MJ, Amaro-Gahete FJ. Different exercise training modalities similarly improve heart rate variability in sedentary middle-aged adults: the FIT-AGEING randomized controlled trial. Eur J Appl Physiol. 2022 Aug;122(8):1863-1874. doi: 10.1007/s00421-022-04957-9. Epub 2022 May 10.
PubMed 35538242
Dote-Montero M, De-la-O A, Jurado-Fasoli L, Ruiz JR, Castillo MJ, Amaro-Gahete FJ. The effects of three types of exercise training on steroid hormones in physically inactive middle-aged adults: a randomized controlled trial. Eur J Appl Physiol. 2021 Aug;121(8):2193-2206. doi: 10.1007/s00421-021-04692-7. Epub 2021 Apr 22.
PubMed 33890158
Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
PubMed 33549436
De-la-O A, Jurado-Fasoli L, Castillo MJ, Gutierrez A, Amaro-Gahete FJ. 1,25-Dihydroxyvitamin D and S-Klotho Plasma Levels: The Relationship Between Two Renal Antiaging Biomarkers Mediated by Bone Mineral Density in Middle-Aged Sedentary Adults. Rejuvenation Res. 2021 Jun;24(3):227-233. doi: 10.1089/rej.2020.2384. Epub 2021 Mar 5.
PubMed 33487127
Amaro-Gahete FJ, Sanchez-Delgado G, Ara I, R Ruiz J. Cardiorespiratory Fitness May Influence Metabolic Inflexibility During Exercise in Obese Persons. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5780-5790. doi: 10.1210/jc.2019-01225.
PubMed 31322652
Jurado-Fasoli L, Amaro-Gahete FJ, De-la-O A, Castillo MJ. Impact of different exercise training modalities on energy and nutrient intake and food consumption in sedentary middle-aged adults: a randomised controlled trial. J Hum Nutr Diet. 2020 Feb;33(1):86-97. doi: 10.1111/jhn.12673. Epub 2019 Jul 3.
PubMed 31270896

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Recruiting
Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases
Adapted Physical Activity, Smartwatches

All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).
ClinicalTrials.gov ID: NCT03334357
Acronym / sponsor ID: FIT-AGING / FPU14/04172
Conditions: Physical Activity, Aging
Keywords: Physical fitness, Klotho, Training, HIIT, WB-EMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Manuel Castillo GarzónUniversity, hospital or other
Study start: 1 Jun 2016 (actual)
Primary completion: 23 Dec 2017 (actual)
Study completion: 23 Dec 2017 (actual)
First posted: 7 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Control	No intervention	–Non-Exercise group. We will provide general advices to control group participants thought an information meeting performed by a graduate in Sport Sciences. It will recommended to follow the physical activity recommendations for adults provided by World Health Organization
PAR group	Experimental	Other: PARThe volume in PAR is based on the minimum physical activity recommended (150min/week at moderate intensity). Intensity selected for PAR aerobic training is 60-65% HRres. Strength intensity selected was 40-50% of 1 RM. Frequency. PAR group will train 3 days/week, the minimum frequency recommended. Exercises programmed for the aerobic exercise are treadmill, cycle-ergometer and elliptical ergometer in aerobic training part and weight bearing and guided pneumatic machines (involved major upper and lower body muscle group) in resistance training. Training load variation. We propose a gradual progression to control the exercise dose Training periodization divided in two phases of 5 weeks each one, starting with a familiarization phase (2 weeks). Training sessions. Sessions start with a dynamic standardized warm up, which include several muscle activation exercises. Aerobic sessions include compensatory exercises. Training session will be ended with a cooling-down protocol
HIIT group.	Experimental	Other: HIITThe volume in HIIT 40-65 min/week at high intensity. Intensity. Two different protocols: HIIT with long intervals (Type A session), which intensity will be >95% VO2max and HIIT with short intervals (Type B session), >120% VO2max. Training frequency two times/week. Type of exercise. Type A session are walking in treadmill with personalized slopes. Eight weight-bearing exercises in circuit form, type B session. Training load variation. Gradual progression to control the exercise dose. Training periodization divided in: familiarization phase, phase I, phase II. Training sessions. Type A: 5 minutes in treadmill at 60% VO2max. After warm-up, participants complete sets corresponding to each training session following the corresponding characteristics. Type B: eight weight-bearing exercises (in circuit form) two times/set with an active rest (walking at 60%VO2max) as many times at as defined. Training session will be ended with a cooling-down protocol
WB-EMS group.	Experimental	Other: WB-EMSWB-EMS training program will be the same than HIIT intervention related to volume, intensity, frequency, type of exercise, training load variation, training periodization and training session. However, electrical impulse will be included in order to assess if WB-EMS training will produce an added effect compared to HIIT. Electrical parameters: We will apply a frequency of 15-33 Hz in type A session. And, we will apply a frequency of 35-75 Hz in type B session. Intensity will be 80-100 mA. Impulse Width adjusted in relation to body segment: thigh zone (400μsec), glute zone (350μsec), abdominal zone (300μsec), dorsal zone (250μsec), cervical (200μsec), chest zone (200μsec) and arm zone (200μsec). Duty cycle. We have programmed a duty cycle of 50-67% in type B session, but duty cycle in type A session will be 99%. RPE impulse: the impulse intensity was individually adapted to generate similar values of rate of perceived exertion (RPE) in Borg CR-10 Scale "5" of "9"

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age: 40-65 years
BMI:18.5-35 kg/m2
Not engaged in regular physical activity >20min on >3days/week
Not participating in a weight loss programme
Stable weight over the last 5 months (body weight changes>5kg)

Key exclusion criteria (8 listed)

History of cardiovascular disease
Diabetes
Pregnancy or planning to get pregnant during study period
Beta blockers or benzodiapezins use
Taking medication for thyroid

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PAR	Other	PAR group
HIIT	Other	HIIT group.
WB-EMS	Other	WB-EMS group.

Primary outcome

α-Klotho protein
Time frame: Baseline and through study completion, an average of 12 weeks.
Plasma Klotho concentrations will be measured by ELISA using a soluble α-Klotho ELISA assay kit.

13 secondary outcomes

Physical fitness: cardiorespiratory fitness
Time frame: Baseline and through study completion, an average of 12 weeks.
Physical fitness: muscular strength.
Time frame: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
Body composition.
Time frame: Baseline and through study completion, an average of 12 weeks.
Resting energy expenditure.
Time frame: Baseline and through study completion, an average of 12 weeks.
Hearth Rate Variability (HRV).
Time frame: Baseline and through study completion, an average of 12 weeks.
Biochemical profile.
Time frame: Baseline and through study completion, an average of 12 weeks.
Physical activity.
Time frame: Baseline and through study completion, an average of 12 weeks.
Reaction time.
Time frame: Baseline and through study completion, an average of 12 weeks.
Cognitive test.
Time frame: Baseline and through study completion, an average of 12 weeks.
Dietary assessment.
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Anthopometric measures.
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Sleep quality.
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Hormones profile
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Derived from this study: PubMed 35538242Navarro-Lomas G, Dote-Montero M, Alcantara JMA, Plaza-Florido A, Castillo MJ, Amaro-Gahete FJ. Different exercise training modalities similarly improve heart rate variability in sedentary middle-aged adults: the FIT-AGEING randomized controlled trial. Eur J Appl Physiol. 2022 Aug;122(8):1863-1874. doi: 10.1007/s00421-022-04957-9. Epub 2022 May 10.
Derived from this study: PubMed 33890158Dote-Montero M, De-la-O A, Jurado-Fasoli L, Ruiz JR, Castillo MJ, Amaro-Gahete FJ. The effects of three types of exercise training on steroid hormones in physically inactive middle-aged adults: a randomized controlled trial. Eur J Appl Physiol. 2021 Aug;121(8):2193-2206. doi: 10.1007/s00421-021-04692-7. Epub 2021 Apr 22.
Derived from this study: PubMed 33549436Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
Derived from this study: PubMed 33487127De-la-O A, Jurado-Fasoli L, Castillo MJ, Gutierrez A, Amaro-Gahete FJ. 1,25-Dihydroxyvitamin D and S-Klotho Plasma Levels: The Relationship Between Two Renal Antiaging Biomarkers Mediated by Bone Mineral Density in Middle-Aged Sedentary Adults. Rejuvenation Res. 2021 Jun;24(3):227-233. doi: 10.1089/rej.2020.2384. Epub 2021 Mar 5.
Derived from this study: PubMed 31322652Amaro-Gahete FJ, Sanchez-Delgado G, Ara I, R Ruiz J. Cardiorespiratory Fitness May Influence Metabolic Inflexibility During Exercise in Obese Persons. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5780-5790. doi: 10.1210/jc.2019-01225.
Derived from this study: PubMed 31270896Jurado-Fasoli L, Amaro-Gahete FJ, De-la-O A, Castillo MJ. Impact of different exercise training modalities on energy and nutrient intake and food consumption in sedentary middle-aged adults: a randomised controlled trial. J Hum Nutr Diet. 2020 Feb;33(1):86-97. doi: 10.1111/jhn.12673. Epub 2019 Jul 3.
Individual participant dataSharing planned: No

Related trials for Physical Activity

Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Recruiting
Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases
Adapted Physical Activity, Smartwatches

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manuel J Castillo Garzón, Professor principal investigator

Universidad de Granada

Questions about this trial

What is this clinical trial studying?

A study testing PAR, HIIT and WB-EMS in people with Physical Activity and Aging, run by Manuel Castillo Garzón.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

α-Klotho protein (time frame: Baseline and through study completion, an average of 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03334357, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.