Dietary ModificationNCT03194334
Creatine, Carnitine and Carnosine in Vegetarians
A study testing Vegetarian diet, creatine and Beta-alanine in people with Dietary Modification, run by University Ghent.
Trial summary
Balanced vegetarian diets are popular and contain health-promoting characteristics. A balanced lacto-ovo-vegetarian diet differs in nutrient intake from an omnivorous diet, e.g. by increased intake of fibre, magnesium and antioxidants, but lower intake of omega-3 fatty acids and vitamin B12. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Vegetarian diet, creatine and Beta-alanine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
Who cannot join
- smoking, chronic use of medication or taking supplements, athletes participating in competitions, vegetarianism or eating meat or fish less than 5 times a week
About this study
Official title: Effect of a 6-month Vegetarian Diet in Omnivorous Women on Body Creatine, Carnitine and Carnosine Stores
Balanced vegetarian diets are popular and contain health-promoting characteristics. A balanced lacto-ovo-vegetarian diet differs in nutrient intake from an omnivorous diet, e.g. by increased intake of fibre, magnesium and antioxidants, but lower intake of omega-3 fatty acids and vitamin B12. However, the impact of reduced to near absent intake of carnitine, carnosine and creatine in a vegetarian diet is less well established and could be relevant in relation to muscle function, exercise capacity and sports performance. Few longitudinal intervention studies investigating the effect of a vegetarian diet on the availability of these compounds currently exist.
This study aimed therefore to investigate the effect of of transiently switching omnivores onto a vegetarian diet for 6 months on muscle and plasma creatine, carnitine and carnosine homeostasis.
We hypothesized that homeostasis of creatine and carnosine would be disrupted when their dietary intake was missing. For carnitine, however, we hypothesized that homeostasis can be maintained given its slow turnover rate and its presence in some non-meat nutrients. A second aim was to investigate whether supplementation of creatine and beta-alanine (the rate-limiting precursor of carnosine synthesis), concurrently with a lacto-ovo-vegetarian diet, was able to correct for potentially emerging deficiencies.
Read the detailed description
Forty healthy female omnivores will be included in this 6-month intervention study. Exclusion criteria are smoking, chronic use of medication, athletes participating in competitions, vegetarianism or eating meat or fish less than 5 times a week. The study is scheduled over a period of 6 months and measurements will be performed 1 week prior to the intervention (0M), after 3 months (3M) and within the last week (6M). Ten women will continue their omnivorous diet throughout the entire study (controls) and the other 30 subjects will switch to a lacto-ovo-vegetarian diet for 6 months. The vegetarian group will be split in 2 groups, matched for age, weight, height and baseline carnosine concentrations in soleus and gastrocnemius medialis muscles. Fifteen of them will be supplemented with beta-alanine and creatine (Veg+Suppl) and the other 15 women will receive a placebo (Veg+Pla). A co-worker, not involved in the study design and analysis, will perform the randomisation and will prepare the containers with supplements. With regard to supplementation, the study is double-blind placebo-controlled. The lacto-ovo-vegetarian diet consists of vegetables, fruits, seeds, grains, meat substitutes, eggs and dairy products and the exclusion of meat, poultry and fish. Subjects will complete a 3 day food diary at the start and after 3 months and will receive nutritional advice by a dietician during the study to prevent deficiencies in macronutrients and micronutrients. Furthermore, vegetarian recipes will be provided by email to support the subjects in their vegetarian diet.
The supplementation protocol includes simultaneously daily oral administration of creatine monohydrate (Creapure®, AlzChem AG, Germany) and slow-release beta-alanine (Carnosyn®, Natural Alternatives International, San Marcos, USA) or a placebo (maltodextrin, Natural spices, France). The supplements are considered as safe and efficacious. The Veg+Suppl group ingests 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day during the intervention period. The Veg+Pla group will be supplemented with an identical number of capsules and tablets of maltodextrin. All subjects are asked not to take any other supplements than those provided by the current study. Compliance will be checked by asking the subjects to return the containers and counting the pills that are left. The control group, who will remain on an omnivorous diet, will not receive any supplements.
Before (0M), after 3 (3M) and 6 months (6M), subjects will perform an incremental cycling test, a fasted venous blood sample and 24hr urine will be collected, a muscle biopsy of the vastus lateralis muscle will be taken and muscle carnosine content will be determined by 1H-MRS.
A two-way analysis of variance (ANOVA) will be used to evaluate plasma and urinary metabolite concentrations, muscle carnosine, muscle biopsy metabolite concentrations, time to exhaustion (TTE) and VO2max with 'group' (Veg+Suppl; Veg+Pla; control) as between-subject factor and 'time' (0M; 3M; 6M) as within-subject factor (SPSS statistical software, SPSS Inc, Chicago, USA). For the analysis of capillary lactate and pH, measurements before and after the incremental cycling test were included as another within factor (start; end). In case of significance, analyses were repeated for each group separately and pairwise comparisons were used to compare the different time points. Values will be presented as mean ± SD and statistical significance threshold will be set at p ≤0.05.
- Conditions
- Dietary Modification
- Being tested
- Vegetarian diet, creatine, Placebo, Beta-alanine
- Keywords
- vegetarianism, creatine, carnosine, carnitine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian dietBehavioural
Also called lacto-ovo-vegetarian diet
creatineDietary supplement
1g creatine/day
PlaceboDietary supplement
pills
Beta-alanineDietary supplement
0.8g beta-alanine per day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | continued their omnivorous diet throughout the entire study |
| Veg+Pla | Experimental | vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine Receives: Behavioral: Vegetarian diet; Dietary Supplement: Placebo |
| Veg+ creatine and beta-alanine | Experimental | switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day Receives: Behavioral: Vegetarian diet; Dietary Supplement: creatine; Dietary Supplement: Beta-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasted Plasma Beta-alanine Concentration
Fasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention
Measured: 6 months
Gastrocnemius Carnosine Concentration
Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Soleus Carnosine Concentration
Soleus carnosine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Plasma Creatine Concentration
Plasma creatine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Plasma Creatinine Concentration
Plasma creatinine at 0, 3 and 6 months of the intervention
Measured: 6 months
Plasma Guanidinoacetate Concentration
Plasma guanidinoacetate at 0, 3 and 6 months of the intervention
Measured: 6 months
Urinary Creatinine Concentration
Urinary creatinine at 0, 3 and 6 months of the intervention
Measured: 6 months
Muscle Creatine Concentration
Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Measured: 3 months
Plasma Carnitine Concentration
plasma free carnitine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Plasma Acetylcarnitine Concentration
plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Plasma Total Carnitine Concentration
plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention
Measured: 6 months
Muscle Carnitine Concentration
muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Measured: 3 months
Muscle Acetylcarnitine Concentration
muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Measured: 3 months
Muscle Total Carnitine Concentration
muscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention
Measured: 3 months
Secondary outcomes (8)
Vitamin D Status
Serum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Urinary Biomarker for Meat Intake: Pi-methyl-histidine
urinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Urinary Biomarker for Meat Intake: Tau-methyl-histidine
urinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
Urinary Biomarker for Meat Intake: Anserine
urinary anserine concentration at 0, 3 and 6 months of the intervention
Measured: 6 months
VO2max
VO2max during incremental cycling test performed at 0, 3 and 6 months
Measured: 6 months
Time to Exhaustion
Time to exhaustion during incremental cycling test performed at 0, 3 and 6 months
Measured: 6 months
Capillary Lactate
capillary lactate at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months
Measured: 6 months
Capillary pH
capillary pH at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies 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
- Model description
- The study was scheduled over a period of 6 months. Of the 40 subjects, 10 women will continue their omnivorous diet throughout the entire study (controls) and the other 30 subjects will switch to a lacto-ovo-vegetarian diet for 6 months. The vegetarian group will be split in 2 groups, matched for age, weight, height and baseline carnosine concentrations in soleus and gastrocnemius medialis muscles. Fifteen of them will be supplemented with beta-alanine and creatine (Veg+Suppl) and the other 15 women will receive a placebo (Veg+Pla).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Derave, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194334
- Sponsor's protocol ID
- EC/2012/666
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2017
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual data will not be made available to other researchers
Publications
Van Dyck D, Herman K, Poppe L, Crombez G, De Bourdeaudhuij I, Gheysen F. Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 7;21(10):e13219. doi: 10.2196/13219.
PubMed 31593541Blancquaert L, Baguet A, Bex T, Volkaert A, Everaert I, Delanghe J, Petrovic M, Vervaet C, De Henauw S, Constantin-Teodosiu D, Greenhaff P, Derave W. Changing to a vegetarian diet reduces the body creatine pool in omnivorous women, but appears not to affect carnitine and carnosine homeostasis: a randomised trial. Br J Nutr. 2018 Apr;119(7):759-770. doi: 10.1017/S000711451800017X.
PubMed 29569535
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 6-month Vegetarian Diet in Omnivorous Women on Body Creatine, Carnitine and Carnosine Stores
- ClinicalTrials.gov ID
- NCT03194334
- Acronym / sponsor ID
- EC/2012/666
- Conditions
- Dietary Modification
- Keywords
- vegetarianism, creatine, carnosine, carnitine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Balanced vegetarian diets are popular and contain health-promoting characteristics. A balanced lacto-ovo-vegetarian diet differs in nutrient intake from an omnivorous diet, e.g. by increased intake of fibre, magnesium and antioxidants, but lower intake of omega-3 fatty acids and vitamin B12. However, the impact of reduced to near absent intake of carnitine, carnosine and creatine in a vegetarian diet is less well established and could be relevant in relation to muscle function, exercise capacity and sports performance. Few longitudinal intervention studies investigating the effect of a vegetarian diet on the availability of these compounds currently exist.
This study aimed therefore to investigate the effect of of transiently switching omnivores onto a vegetarian diet for 6 months on muscle and plasma creatine, carnitine and carnosine homeostasis.
We hypothesized that homeostasis of creatine and carnosine would be disrupted when their dietary intake was missing. For carnitine, however, we hypothesized that homeostasis can be maintained given its slow turnover rate and its presence in some non-meat nutrients. A second aim was to investigate whether supplementation of creatine and beta-alanine (the rate-limiting precursor of carnosine synthesis), concurrently with a lacto-ovo-vegetarian diet, was able to correct for potentially emerging deficiencies.
Detailed description
Forty healthy female omnivores will be included in this 6-month intervention study. Exclusion criteria are smoking, chronic use of medication, athletes participating in competitions, vegetarianism or eating meat or fish less than 5 times a week. The study is scheduled over a period of 6 months and measurements will be performed 1 week prior to the intervention (0M), after 3 months (3M) and within the last week (6M). Ten women will continue their omnivorous diet throughout the entire study (controls) and the other 30 subjects will switch to a lacto-ovo-vegetarian diet for 6 months. The vegetarian group will be split in 2 groups, matched for age, weight, height and baseline carnosine concentrations in soleus and gastrocnemius medialis muscles. Fifteen of them will be supplemented with beta-alanine and creatine (Veg+Suppl) and the other 15 women will receive a placebo (Veg+Pla). A co-worker, not involved in the study design and analysis, will perform the randomisation and will prepare the containers with supplements. With regard to supplementation, the study is double-blind placebo-controlled. The lacto-ovo-vegetarian diet consists of vegetables, fruits, seeds, grains, meat substitutes, eggs and dairy products and the exclusion of meat, poultry and fish. Subjects will complete a 3 day food diary at the start and after 3 months and will receive nutritional advice by a dietician during the study to prevent deficiencies in macronutrients and micronutrients. Furthermore, vegetarian recipes will be provided by email to support the subjects in their vegetarian diet.
The supplementation protocol includes simultaneously daily oral administration of creatine monohydrate (Creapure®, AlzChem AG, Germany) and slow-release beta-alanine (Carnosyn®, Natural Alternatives International, San Marcos, USA) or a placebo (maltodextrin, Natural spices, France). The supplements are considered as safe and efficacious. The Veg+Suppl group ingests 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day during the intervention period. The Veg+Pla group will be supplemented with an identical number of capsules and tablets of maltodextrin. All subjects are asked not to take any other supplements than those provided by the current study. Compliance will be checked by asking the subjects to return the containers and counting the pills that are left. The control group, who will remain on an omnivorous diet, will not receive any supplements.
Before (0M), after 3 (3M) and 6 months (6M), subjects will perform an incremental cycling test, a fasted venous blood sample and 24hr urine will be collected, a muscle biopsy of the vastus lateralis muscle will be taken and muscle carnosine content will be determined by 1H-MRS.
A two-way analysis of variance (ANOVA) will be used to evaluate plasma and urinary metabolite concentrations, muscle carnosine, muscle biopsy metabolite concentrations, time to exhaustion (TTE) and VO2max with 'group' (Veg+Suppl; Veg+Pla; control) as between-subject factor and 'time' (0M; 3M; 6M) as within-subject factor (SPSS statistical software, SPSS Inc, Chicago, USA). For the analysis of capillary lactate and pH, measurements before and after the incremental cycling test were included as another within factor (start; end). In case of significance, analyses were repeated for each group separately and pairwise comparisons were used to compare the different time points. Values will be presented as mean ± SD and statistical significance threshold will be set at p ≤0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was scheduled over a period of 6 months. Of the 40 subjects, 10 women will continue their omnivorous diet throughout the entire study (controls) and the other 30 subjects will switch to a lacto-ovo-vegetarian diet for 6 months. The vegetarian group will be split in 2 groups, matched for age, weight, height and baseline carnosine concentrations in soleus and gastrocnemius medialis muscles. Fifteen of them will be supplemented with beta-alanine and creatine (Veg+Suppl) and the other 15 women will receive a placebo (Veg+Pla).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –continued their omnivorous diet throughout the entire study |
| Veg+Pla | Experimental | Behavioral: Vegetarian diet, Dietary Supplement: Placebovegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine |
| Veg+ creatine and beta-alanine | Experimental | Behavioral: Vegetarian diet, Dietary Supplement: creatine, Dietary Supplement: Beta-alanineswitch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with 1 g of creatine monohydrate (2 capsules of 500 mg) and 0.8 g of beta-alanine (1 Carnosyn® tablet) each day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women
Key exclusion criteria (1 listed)
- smoking, chronic use of medication or taking supplements, athletes participating in competitions, vegetarianism or eating meat or fish less than 5 times a week
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 |
|---|---|---|
| Vegetarian dietAlso: lacto-ovo-vegetarian diet | Behavioural | Veg+ creatine and beta-alanine, Veg+Pla |
| creatine1g creatine/day | Dietary supplement | Veg+ creatine and beta-alanine |
| Placebopills | Dietary supplement | Veg+Pla |
| Beta-alanine0.8g beta-alanine per day | Dietary supplement | Veg+ creatine and beta-alanine |
Primary outcome
Fasted Plasma Beta-alanine Concentration
Time frame: 6 months
Fasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention
Gastrocnemius Carnosine Concentration
Time frame: 6 months
Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention
Soleus Carnosine Concentration
Time frame: 6 months
Soleus carnosine concentration at 0, 3 and 6 months of the intervention
Plasma Creatine Concentration
Time frame: 6 months
Plasma creatine concentration at 0, 3 and 6 months of the intervention
Plasma Creatinine Concentration
Time frame: 6 months
Plasma creatinine at 0, 3 and 6 months of the intervention
Plasma Guanidinoacetate Concentration
Time frame: 6 months
Plasma guanidinoacetate at 0, 3 and 6 months of the intervention
Urinary Creatinine Concentration
Time frame: 6 months
Urinary creatinine at 0, 3 and 6 months of the intervention
Muscle Creatine Concentration
Time frame: 3 months
Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Plasma Carnitine Concentration
Time frame: 6 months
plasma free carnitine concentration at 0, 3 and 6 months of the intervention
Plasma Acetylcarnitine Concentration
Time frame: 6 months
plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention
Plasma Total Carnitine Concentration
Time frame: 6 months
plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention
Muscle Carnitine Concentration
Time frame: 3 months
muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Muscle Acetylcarnitine Concentration
Time frame: 3 months
muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Muscle Total Carnitine Concentration
Time frame: 3 months
muscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention
8 secondary outcomes
Vitamin D Status
Time frame: 6 months
Urinary Biomarker for Meat Intake: Pi-methyl-histidine
Time frame: 6 months
Urinary Biomarker for Meat Intake: Tau-methyl-histidine
Time frame: 6 months
Urinary Biomarker for Meat Intake: Anserine
Time frame: 6 months
VO2max
Time frame: 6 months
Time to Exhaustion
Time frame: 6 months
Capillary Lactate
Time frame: 6 months
Capillary pH
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31593541Van Dyck D, Herman K, Poppe L, Crombez G, De Bourdeaudhuij I, Gheysen F. Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 7;21(10):e13219. doi: 10.2196/13219.
- Derived from this study: PubMed 29569535Blancquaert L, Baguet A, Bex T, Volkaert A, Everaert I, Delanghe J, Petrovic M, Vervaet C, De Henauw S, Constantin-Teodosiu D, Greenhaff P, Derave W. Changing to a vegetarian diet reduces the body creatine pool in omnivorous women, but appears not to affect carnitine and carnosine homeostasis: a randomised trial. Br J Nutr. 2018 Apr;119(7):759-770. doi: 10.1017/S000711451800017X.
- Individual participant dataSharing planned: No. individual data will not be made available to other researchers
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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.
Wim Derave, Professor principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Vegetarian diet, creatine and Beta-alanine in people with Dietary Modification, run by University Ghent.
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 1 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 28 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fasted Plasma Beta-alanine Concentration (time frame: 6 months). The study lists 14 primary outcomes in all. 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 NCT03194334, which also lists 2 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 28 Feb 2019.