Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
Healthy Volunteers
ID06677359

Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults

Led by Fundacion Miguel Servet · Updated on 2025-06-12

120

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether creatine supplementation, with or without a multicomponent exercise program, can improve physical function and cognitive abilities in people over 75 years old. The study aims to understand if creatine alone or combined with strength, balance, and walking exercises can provide benefits and if it is safe for older adults. This research hopes to improve quality of life for elderly patients and support better healthcare strategies. Participants are randomly assigned to one of four groups: creatine supplementation alone, placebo supplementation alone, placebo with exercise, or creatine with exercise. The multicomponent training includes supervised sessions focused on strength, balance, and walking tailored to each participant's abilities. The exercise program happens several times a week, and creatine or placebo is taken alongside. The intervention lasts around 5 weeks, with follow-up assessments after discharge. During the study, participants undergo tests measuring physical function, strength, and cognition using standardized tools like the Timed Up and Go Test and Mini-Mental State Examination. Quality of life is assessed through surveys before and after the intervention. Follow-up visits at 5 weeks post-discharge track progress to capture any lasting benefits. Safety and muscle status are also monitored throughout the approximately 10-week study period.

CONDITIONS

Brief Title

Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults.

Who Can Participate

Age: 75Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age: 75 years or older.
  • Able to ambulate with or without personal or technical assistance.
  • Life expectancy of 6 months or more.
  • Barthel Index greater than 60.
  • Provided informed consent by patient or legal representative.
Not Eligible

You will not qualify if you...

  • Global Deterioration Scale score of 6 or 7.
  • Food or drug allergies or intolerances.
  • Swallowing difficulties (dysphagia).
  • Any medical condition that makes physical exercise unsafe.
  • Creatine supplementation for less than 6 weeks.
  • Consuming more than 200 mg of caffeine daily.
  • Participation in supervised physical training.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 weeks

Participants receive creatine monohydrate supplementation and/or participate in a multicomponent exercise program designed to improve strength, balance, and mobility. They undergo functional and cognitive assessments during this period.

Several supervised exercise sessions per week and baseline assessments

Follow-up

Duration - 5 weeks post-discharge

Participants attend follow-up assessments to monitor changes in functional capacity, cognitive status, and quality of life after the intervention.

1 follow-up visit at 5 weeks post-discharge

Trial Site Locations

Total: 1 location

1

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

N

Nicolas Martinez-Velilla, PhD

F

Fabricio Zambom, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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