SarcopeniaCREGAASNCT04652921
Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)
A study testing Creatine-guanidinoacetic acid and Inulin in people with Sarcopenia, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Creatine-guanidinoacetic acid and Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Sep 2020to 31 Dec 2021
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 70 years
- Free of acute disorders
Who cannot join
- History of dietary supplement use during the past 4 weeks
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly
Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Among potential therapeutic candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine mixture was found to be superior than creatine itself to effectively improves bioenergetics in the human brain and muscle in healthy humans, perhaps due to the unique transportability features of this combination. Here, we plan to evaluate does creatine-GAA supplementation affects various biomarkers of sarcopenia in elderly.
- Conditions
- Sarcopenia
- Being tested
- Creatine-guanidinoacetic acid, Inulin
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine-guanidinoacetic acidDietary supplement
A dietary supplement provided as powder dissolved in a glass of water
InulinOther
A dietary supplement provided as powder dissolved in a glass of water
| Study group | Role | What they receive |
|---|---|---|
| Creatine-guanidinoacetic acid | Experimental | 2 grams of creatine and 2 grams of GAA Administered one dose two times per day on an empty stomach in the morning and at the evening Receives: Dietary Supplement: Creatine-guanidinoacetic acid |
| Inulin | Placebo comparator | 4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening Receives: Other: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscular strength
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Secondary outcomes (4)
Change in muscle mass
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in muscle metabolites evaluated with MR spectroscopy
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in cognitive performance evaluated with Mini-Mental State Exam test
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Change in serum creatine
Baseline vs. 6 months
Measured: Baseline vs. 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Sep 2020
- Primary completion15 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652921
- Sponsor's protocol ID
- DS-04/2020
- Acronym
- CREGAAS
- Status last verified
- Oct 2022
- First submitted
- 26 Nov 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly
- ClinicalTrials.gov ID
- NCT04652921
- Acronym / sponsor ID
- CREGAAS / DS-04/2020
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Dec 2020 (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.
Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Among potential therapeutic candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine mixture was found to be superior than creatine itself to effectively improves bioenergetics in the human brain and muscle in healthy humans, perhaps due to the unique transportability features of this combination. Here, we plan to evaluate does creatine-GAA supplementation affects various biomarkers of sarcopenia in elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine-guanidinoacetic acid | Experimental | Dietary Supplement: Creatine-guanidinoacetic acid2 grams of creatine and 2 grams of GAA Administered one dose two times per day on an empty stomach in the morning and at the evening |
| Inulin | Placebo comparator | Other: Inulin4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 70 years
- Free of acute disorders
Key exclusion criteria (1 listed)
- History of dietary supplement use during the past 4 weeks
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 |
|---|---|---|
| Creatine-guanidinoacetic acidA dietary supplement provided as powder dissolved in a glass of water | Dietary supplement | Creatine-guanidinoacetic acid |
| InulinA dietary supplement provided as powder dissolved in a glass of water | Other | Inulin |
Primary outcome
Change in muscular strength
Time frame: Baseline vs. 6 months post-intervention
Baseline vs. 6 months
4 secondary outcomes
Change in muscle mass
Time frame: Baseline vs. 6 months post-intervention
Change in muscle metabolites evaluated with MR spectroscopy
Time frame: Baseline vs. 6 months post-intervention
Change in cognitive performance evaluated with Mini-Mental State Exam test
Time frame: Baseline vs. 6 months post-intervention
Change in serum creatine
Time frame: Baseline vs. 6 months post-intervention
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 1 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine-guanidinoacetic acid and Inulin in people with Sarcopenia, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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 2 inclusion and 1 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in muscular strength (time frame: Baseline vs. 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.