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Het acute effect van beta-guanidinopropionzuur en creatine


- candidate number16777
- NTR NumberNTR4444
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2014
- Secondary IDsNL38368.018.12 
- Public TitleHet acute effect van beta-guanidinopropionzuur en creatine
- Scientific TitleAcute effect of beta-guanidinopropionic acid and creatine in healthy men: a randomized placebo-controlled, double-blind study
- ACRONYMABC trial
- hypothesisBeta-guanidinopropionic acid (GPA), a creatine analogue, can be obtained without prescription on the internet, and is used by sportsmen to increase muscle mass and endurance capacity. In contrast, creatine is used to improve short-duration/high-intensity exercise. Although previous studies assessed the effect on muscle performance of creatine in humans, and of GPA in animals, none of these studies reported the effect on peripheral hemodynamic parameters. Our new data indicate a potential blood pressure lowering effect of GPA in hypertensive animals. However, to our knowledge, there are no published human data on the effects and side effects of GPA.
Therefore, in this RCT we will assess in human volunteers, the tolerability of GPA as a primary outcome, and the haemodynamic effects in comparison with creatine as a secondary outcome.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers, Blood pressure, Platelet aggregation, Hemodynamics, Creatine, Beta-guanidinopropionic acid
- Inclusion criteriaHealthy men, 18-50 years old, with a body mass index from 18.5 to 29.9 kg/m2
- Exclusion criteriaglucose, lipid spectrum, thyroid, kidney, or liver abnormalities, (history of) cardiovascular disease including TIA and stroke; CK-increasing drugs including statins; use of acetylsalicyl acid or non-steroidal anti-inflammatory drugs (NSAIDs) in the two week prior to the visits, neuromuscular or endocrine disorders; vasculitis; HIV infection; infectious hepatitis; personal or family history of bleeding disorders, sickle cell disease; smoking; current use or use within 2 months prior to start of the trial of beta-guanidinopropionic acid or creatine.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mrt-2014
- planned closingdate31-dec-2014
- Target number of participants24
- InterventionsThe participants will be asked to come to the hospital an overnight fasts.
At visit 1 (day 0), after baseline measurements, they will receive a 24 h blood pressure measurement device and a container to collect 24h urine.
At visit 2, the next day (day 1 of the trial supplements), they will take first capsules with GPA 100 mg, creatine 5 g, or placebo in the hospital (Figure 4B) after receiving a 24 h blood pressure measurement device and a container to collect 24h urine.
At visit 3 (day 2 of the trial supplements), haemodynamic and blood tests will be performed, trial supplements will be taken, and participants will receive trial supplements to take at home at day 3, 4,5, and 6 after an overnight fast.
The participants return to the hospital for visit 4 at day 7 of the trial supplements, to take the final trial supplements after receiving a 24 h blood pressure measurement device and a container to collect 24h urine.
They will return for visit 5 on day 8 for haemodynamic measurements and blood tests.
The 6th and last visit is at day 21, for the final assessment of tolerability.
- Primary outcomeTolerability of GPA after oral administration in healthy male volunteers versus placebo
- Secondary outcomeHemodynamic parameters (Resting blood pressure; heart rate, cardiac output and total peripheral resistance, measured non-invasively) and ADP-induced platelet aggregation after oral administration of GPA in healthy male volunteers versus placebo and creatine.
- TimepointsT=0 Baseline measurements (before intake of trial supplements or placebo)

Primary outcome: General history taking

Secondary Outcome:
Hemodynamic parameters (Resting blood pressure; heart rate, cardiac output and total peripheral resistance, measured non-invasively) and ADP-induced platelet aggregation.

T=2 days (After 1 day of use of trial supplements or placebo)
Primary Outcome: The probability of adverse drug reactions will be estimated with the validated Naranjo adverse drug reaction probability scale.
Secondary Outcome: Hemodynamic parameters (Resting blood pressure; heart rate, cardiac output and total peripheral resistance, measured non-invasively)

T=7 days (after 7 days of use of trial supplements or placebo)
Primary Outcome: The probability of the adverse drug reactions will be estimated with the validated Naranjo adverse drug reaction probability scale.
Secondary Outcome: Hemodynamic parameters (Resting blood pressure; heart rate, cardiac output and total peripheral resistance, measured non-invasively) and ADP-induced platelet aggregation.

T=21 days, 2 weeks after stopping the use of trial supplements or placebo
Primary Outcome: The probability of adverse drug reactions will be estimated with the validated Naranjo adverse drug reaction probability scale.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. L.M. Brewster
- CONTACT for SCIENTIFIC QUERIESDr. L.M. Brewster
- Sponsor/Initiator Academic Medical Center (AMC), Department of Vascular Medicine, Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryRationale: Beta-guanidinopropionic acid (GPA), a creatine analogue, can be obtained without prescription on the internet, and is used by sportsmen to increase muscle mass and endurance capacity. In contrast, creatine is used to improve short-duration/high-intensity exercise. Although previous studies assessed the effect on muscle performance of creatine in humans, and of GPA in animals, none of these studies reported the effect on peripheral hemodynamic parameters, or the effect on ADP-dependent platelet aggregation. Our new data from animal studies indicate an anti-hypertensive effect of GPA. However, to our knowledge, there are no published human data on the effects and side effects of GPA.
Objective: In this study we will assess in human volunteers, the tolerability of GPA 100 mg during 1 week, as a primary outcome, compared to placebo and creatine 5 g.
Study design: Randomized, double-blind, placebo-controlled, double-dummy intervention study.
Study population: 24 healthy male volunteers, 18-50 years old recruited in the Netherlands.
Intervention: One week of daily oral administration of GPA 100 mg, creatine 5 g, or placebo.
Main study parameters/endpoints: Tolerability for GPA assessed with a questionnaire; hemodynamic parameters, including blood pressure, heart rate, cardiac output and total peripheral resistance; biochemical parameters, including serum CK, GPA, creatine, glucose, insuline, creatinine after acute oral administration of GPA and one week of intervention with GPA or creatine; ADP-induced platelet aggregation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, we will assess the effects of GPA, a freely available creatine analogue, and creatine in healthy subjects. This will not directly benefit the participants. The risks associated with participation can be considered negligible and the burden can be considered minimal.
- Main changes (audit trail)
- RECORD9-mrt-2014 - 20-aug-2015


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