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Creatine, Carnitine and Carnosine in Vegetarians

Effect of a 6-month Vegetarian Diet in Omnivorous Women on Body Creatine, Carnitine and Carnosine Stores

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03194334
Enrollment
40
Registered
2017-06-21
Start date
2012-12-31
Completion date
2013-06-30
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification

Keywords

vegetarianism, creatine, carnosine, carnitine

Brief 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. 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.

Interventions

BEHAVIORALVegetarian diet
DIETARY_SUPPLEMENTcreatine

1g creatine/day

DIETARY_SUPPLEMENTPlacebo

pills

DIETARY_SUPPLEMENTBeta-alanine

0.8g beta-alanine per day

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

A co-worker, not involved in the study design and analysis, will perform the randomisation and will prepare the containers with supplements. Only the control group will know that they are part of the control group (continuing omnivorous diet). For the vegetarian groups, subject will not know whether they are in the supplemented group or not because placebo supplements will be used

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* women

Exclusion criteria

* smoking, chronic use of medication or taking supplements, athletes participating in competitions, vegetarianism or eating meat or fish less than 5 times a week

Design outcomes

Primary

MeasureTime frameDescription
Fasted Plasma Beta-alanine Concentration6 monthsFasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention
Gastrocnemius Carnosine Concentration6 monthsGastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention
Soleus Carnosine Concentration6 monthsSoleus carnosine concentration at 0, 3 and 6 months of the intervention
Plasma Creatine Concentration6 monthsPlasma creatine concentration at 0, 3 and 6 months of the intervention
Plasma Creatinine Concentration6 monthsPlasma creatinine at 0, 3 and 6 months of the intervention
Plasma Guanidinoacetate Concentration6 monthsPlasma guanidinoacetate at 0, 3 and 6 months of the intervention
Urinary Creatinine Concentration6 monthsUrinary creatinine at 0, 3 and 6 months of the intervention
Muscle Creatine Concentration3 monthsMuscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Plasma Carnitine Concentration6 monthsplasma free carnitine concentration at 0, 3 and 6 months of the intervention
Plasma Acetylcarnitine Concentration6 monthsplasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention
Plasma Total Carnitine Concentration6 monthsplasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention
Muscle Carnitine Concentration3 monthsmuscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Muscle Acetylcarnitine Concentration3 monthsmuscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Muscle Total Carnitine Concentration3 monthsmuscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention

Secondary

MeasureTime frameDescription
Vitamin D Status6 monthsSerum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention
Urinary Biomarker for Meat Intake: Pi-methyl-histidine6 monthsurinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Urinary Biomarker for Meat Intake: Tau-methyl-histidine6 monthsurinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Urinary Biomarker for Meat Intake: Anserine6 monthsurinary anserine concentration at 0, 3 and 6 months of the intervention
VO2max6 monthsVO2max during incremental cycling test performed at 0, 3 and 6 months
Time to Exhaustion6 monthsTime to exhaustion during incremental cycling test performed at 0, 3 and 6 months
Capillary Lactate6 monthscapillary lactate at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months
Capillary pH6 monthscapillary pH at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months

Participant flow

Participants by arm

ArmCount
Control
continued their omnivorous diet throughout the entire study
10
Veg+Pla
vegetarian + placebo: switch to a lacto-ovo-vegetarian diet for 6 months and are supplemented with placebo pills instead of beta-alanine and creatine Vegetarian diet Placebo: pills
15
Veg+Suppl
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 Vegetarian diet creatine and beta-alanine
15
Total40

Baseline characteristics

CharacteristicControlTotalVeg+SupplVeg+Pla
Age, Continuous25.9 years
STANDARD_DEVIATION 9
25.6 years
STANDARD_DEVIATION 7.3
25.5 years
STANDARD_DEVIATION 6.6
26.1 years
STANDARD_DEVIATION 7.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants40 Participants15 Participants15 Participants
Region of Enrollment
Belgium
10 Participants40 Participants15 Participants15 Participants
Sex: Female, Male
Female
10 Participants40 Participants15 Participants15 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 150 / 14
other
Total, other adverse events
0 / 100 / 150 / 14
serious
Total, serious adverse events
0 / 100 / 150 / 14

Outcome results

Primary

Fasted Plasma Beta-alanine Concentration

Fasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlFasted Plasma Beta-alanine Concentration3 months3.76 µMStandard Deviation 2.58
ControlFasted Plasma Beta-alanine ConcentrationBasline3.37 µMStandard Deviation 1.96
ControlFasted Plasma Beta-alanine Concentration6 months3.9 µMStandard Deviation 2.88
Veg+PlaFasted Plasma Beta-alanine Concentration3 months5.11 µMStandard Deviation 1.99
Veg+PlaFasted Plasma Beta-alanine ConcentrationBasline5.19 µMStandard Deviation 2.26
Veg+PlaFasted Plasma Beta-alanine Concentration6 months5.59 µMStandard Deviation 2.63
Veg+SupplFasted Plasma Beta-alanine ConcentrationBasline4.56 µMStandard Deviation 2.74
Veg+SupplFasted Plasma Beta-alanine Concentration6 months5.42 µMStandard Deviation 3.99
Veg+SupplFasted Plasma Beta-alanine Concentration3 months5.8 µMStandard Deviation 3.24
Primary

Gastrocnemius Carnosine Concentration

Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlGastrocnemius Carnosine Concentration3 months5.58 mMStandard Deviation 0.97
ControlGastrocnemius Carnosine ConcentrationBaseline5.18 mMStandard Deviation 1.21
ControlGastrocnemius Carnosine Concentration6 months5.68 mMStandard Deviation 1.07
Veg+PlaGastrocnemius Carnosine Concentration3 months5.55 mMStandard Deviation 1.4
Veg+PlaGastrocnemius Carnosine ConcentrationBaseline5.16 mMStandard Deviation 1.46
Veg+PlaGastrocnemius Carnosine Concentration6 months5.81 mMStandard Deviation 1.82
Veg+SupplGastrocnemius Carnosine ConcentrationBaseline5.1 mMStandard Deviation 1.61
Veg+SupplGastrocnemius Carnosine Concentration6 months7.19 mMStandard Deviation 2.11
Veg+SupplGastrocnemius Carnosine Concentration3 months6.55 mMStandard Deviation 1.53
Primary

Muscle Acetylcarnitine Concentration

muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlMuscle Acetylcarnitine ConcentrationBaseline3.3 mmol/kg dry weightStandard Deviation 3.2
ControlMuscle Acetylcarnitine Concentration3 months3.6 mmol/kg dry weightStandard Deviation 1.9
Veg+PlaMuscle Acetylcarnitine ConcentrationBaseline4.2 mmol/kg dry weightStandard Deviation 2.4
Veg+PlaMuscle Acetylcarnitine Concentration3 months3.5 mmol/kg dry weightStandard Deviation 4.1
Veg+SupplMuscle Acetylcarnitine ConcentrationBaseline3.3 mmol/kg dry weightStandard Deviation 2.9
Veg+SupplMuscle Acetylcarnitine Concentration3 months3.2 mmol/kg dry weightStandard Deviation 2.5
Primary

Muscle Carnitine Concentration

muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlMuscle Carnitine ConcentrationBaseline13.1 mmol/kg dry weightStandard Deviation 4
ControlMuscle Carnitine Concentration3 months11.5 mmol/kg dry weightStandard Deviation 2.9
Veg+PlaMuscle Carnitine ConcentrationBaseline12.1 mmol/kg dry weightStandard Deviation 4.1
Veg+PlaMuscle Carnitine Concentration3 months11.5 mmol/kg dry weightStandard Deviation 4.9
Veg+SupplMuscle Carnitine ConcentrationBaseline10.7 mmol/kg dry weightStandard Deviation 2.8
Veg+SupplMuscle Carnitine Concentration3 months9.7 mmol/kg dry weightStandard Deviation 3.2
Primary

Muscle Creatine Concentration

Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlMuscle Creatine Concentration3 months142.2 mmol/kgStandard Deviation 12.7
ControlMuscle Creatine ConcentrationBaseline133.2 mmol/kgStandard Deviation 11.6
Veg+PlaMuscle Creatine Concentration3 months128.8 mmol/kgStandard Deviation 11.6
Veg+PlaMuscle Creatine ConcentrationBaseline153.5 mmol/kgStandard Deviation 24
Veg+SupplMuscle Creatine Concentration3 months140.7 mmol/kgStandard Deviation 17.4
Veg+SupplMuscle Creatine ConcentrationBaseline128.2 mmol/kgStandard Deviation 14.9
Primary

Muscle Total Carnitine Concentration

muscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlMuscle Total Carnitine Concentration3 months15.5 mmol/kg dry weightStandard Deviation 3.2
ControlMuscle Total Carnitine ConcentrationBaseline16.5 mmol/kg dry weightStandard Deviation 2.4
Veg+PlaMuscle Total Carnitine ConcentrationBaseline16.3 mmol/kg dry weightStandard Deviation 3.5
Veg+PlaMuscle Total Carnitine Concentration3 months13.6 mmol/kg dry weightStandard Deviation 2.3
Veg+SupplMuscle Total Carnitine ConcentrationBaseline13.9 mmol/kg dry weightStandard Deviation 2.3
Veg+SupplMuscle Total Carnitine Concentration3 months12.7 mmol/kg dry weightStandard Deviation 2.2
Primary

Plasma Acetylcarnitine Concentration

plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Acetylcarnitine Concentration6 months7.15 µmol/LStandard Deviation 1.41
ControlPlasma Acetylcarnitine Concentration3 months6.82 µmol/LStandard Deviation 1.31
ControlPlasma Acetylcarnitine ConcentrationBaseline8.49 µmol/LStandard Deviation 2.24
Veg+PlaPlasma Acetylcarnitine Concentration6 months7.54 µmol/LStandard Deviation 1.67
Veg+PlaPlasma Acetylcarnitine ConcentrationBaseline7.71 µmol/LStandard Deviation 1.95
Veg+PlaPlasma Acetylcarnitine Concentration3 months6.93 µmol/LStandard Deviation 1.78
Veg+SupplPlasma Acetylcarnitine Concentration3 months6.77 µmol/LStandard Deviation 1.33
Veg+SupplPlasma Acetylcarnitine ConcentrationBaseline8.09 µmol/LStandard Deviation 1.98
Veg+SupplPlasma Acetylcarnitine Concentration6 months7.15 µmol/LStandard Deviation 3.16
Primary

Plasma Carnitine Concentration

plasma free carnitine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Carnitine Concentration3 months28.7 µmol/LStandard Deviation 6.11
ControlPlasma Carnitine ConcentrationBaseline30.81 µmol/LStandard Deviation 6.6
ControlPlasma Carnitine Concentration6 months31.71 µmol/LStandard Deviation 6.75
Veg+PlaPlasma Carnitine Concentration3 months26.45 µmol/LStandard Deviation 6.21
Veg+PlaPlasma Carnitine ConcentrationBaseline29.82 µmol/LStandard Deviation 4.45
Veg+PlaPlasma Carnitine Concentration6 months28.23 µmol/LStandard Deviation 4.88
Veg+SupplPlasma Carnitine ConcentrationBaseline28.39 µmol/LStandard Deviation 6.38
Veg+SupplPlasma Carnitine Concentration6 months27.31 µmol/LStandard Deviation 7.8
Veg+SupplPlasma Carnitine Concentration3 months25.71 µmol/LStandard Deviation 6.22
Primary

Plasma Creatine Concentration

Plasma creatine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Creatine Concentration3 months28.1 µmol/LStandard Deviation 11.9
ControlPlasma Creatine ConcentrationBaseline35.7 µmol/LStandard Deviation 19.8
ControlPlasma Creatine Concentration6 months40.6 µmol/LStandard Deviation 21.6
Veg+PlaPlasma Creatine Concentration3 months15.8 µmol/LStandard Deviation 10
Veg+PlaPlasma Creatine ConcentrationBaseline29.7 µmol/LStandard Deviation 15.3
Veg+PlaPlasma Creatine Concentration6 months16.1 µmol/LStandard Deviation 7.9
Veg+SupplPlasma Creatine ConcentrationBaseline27.3 µmol/LStandard Deviation 9.6
Veg+SupplPlasma Creatine Concentration6 months80.7 µmol/LStandard Deviation 65.7
Veg+SupplPlasma Creatine Concentration3 months56.9 µmol/LStandard Deviation 36.3
Primary

Plasma Creatinine Concentration

Plasma creatinine at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Creatinine Concentration3 months96.62 µmol/LStandard Deviation 15.1
ControlPlasma Creatinine ConcentrationBaseline97.33 µmol/LStandard Deviation 7.8
ControlPlasma Creatinine Concentration6 months96.18 µmol/LStandard Deviation 17.5
Veg+PlaPlasma Creatinine Concentration3 months85.68 µmol/LStandard Deviation 30.94
Veg+PlaPlasma Creatinine ConcentrationBaseline79.49 µmol/LStandard Deviation 29.09
Veg+PlaPlasma Creatinine Concentration6 months75.41 µmol/LStandard Deviation 26.35
Veg+SupplPlasma Creatinine ConcentrationBaseline79.9 µmol/LStandard Deviation 15.83
Veg+SupplPlasma Creatinine Concentration6 months88.13 µmol/LStandard Deviation 17.09
Veg+SupplPlasma Creatinine Concentration3 months78.47 µmol/LStandard Deviation 17.8
Primary

Plasma Guanidinoacetate Concentration

Plasma guanidinoacetate at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Guanidinoacetate Concentration3 months2.2 µmol/LStandard Deviation 0.55
ControlPlasma Guanidinoacetate ConcentrationBaseline2.23 µmol/LStandard Deviation 0.49
ControlPlasma Guanidinoacetate Concentration6 months2.42 µmol/LStandard Deviation 0.92
Veg+PlaPlasma Guanidinoacetate Concentration3 months2.05 µmol/LStandard Deviation 0.63
Veg+PlaPlasma Guanidinoacetate ConcentrationBaseline2.06 µmol/LStandard Deviation 0.59
Veg+PlaPlasma Guanidinoacetate Concentration6 months2.0 µmol/LStandard Deviation 0.63
Veg+SupplPlasma Guanidinoacetate ConcentrationBaseline1.95 µmol/LStandard Deviation 0.52
Veg+SupplPlasma Guanidinoacetate Concentration6 months1.75 µmol/LStandard Deviation 0.67
Veg+SupplPlasma Guanidinoacetate Concentration3 months1.87 µmol/LStandard Deviation 0.72
Primary

Plasma Total Carnitine Concentration

plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlPlasma Total Carnitine Concentration3 months37.96 µmol/LStandard Deviation 6.44
ControlPlasma Total Carnitine ConcentrationBaseline41.58 µmol/LStandard Deviation 6.97
ControlPlasma Total Carnitine Concentration6 months41.25 µmol/LStandard Deviation 8.02
Veg+PlaPlasma Total Carnitine Concentration3 months36.16 µmol/LStandard Deviation 7.83
Veg+PlaPlasma Total Carnitine ConcentrationBaseline40.85 µmol/LStandard Deviation 7.42
Veg+PlaPlasma Total Carnitine Concentration6 months38.58 µmol/LStandard Deviation 6.45
Veg+SupplPlasma Total Carnitine ConcentrationBaseline40.24 µmol/LStandard Deviation 5.75
Veg+SupplPlasma Total Carnitine Concentration6 months37.87 µmol/LStandard Deviation 9.51
Veg+SupplPlasma Total Carnitine Concentration3 months35.9 µmol/LStandard Deviation 5.48
Primary

Soleus Carnosine Concentration

Soleus carnosine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlSoleus Carnosine Concentration3 months3.84 mMStandard Deviation 0.74
ControlSoleus Carnosine ConcentrationBaseline3.91 mMStandard Deviation 0.43
ControlSoleus Carnosine Concentration6 months4.0 mMStandard Deviation 0.72
Veg+PlaSoleus Carnosine Concentration3 months3.36 mMStandard Deviation 0.97
Veg+PlaSoleus Carnosine ConcentrationBaseline3.53 mMStandard Deviation 0.94
Veg+PlaSoleus Carnosine Concentration6 months3.65 mMStandard Deviation 1.38
Veg+SupplSoleus Carnosine ConcentrationBaseline3.7 mMStandard Deviation 1.08
Veg+SupplSoleus Carnosine Concentration6 months4.67 mMStandard Deviation 1.38
Veg+SupplSoleus Carnosine Concentration3 months4.72 mMStandard Deviation 1.11
Primary

Urinary Creatinine Concentration

Urinary creatinine at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlUrinary Creatinine Concentration6 months990.25 mg/24hStandard Deviation 298.77
ControlUrinary Creatinine ConcentrationBaseline1298.62 mg/24hStandard Deviation 269.46
ControlUrinary Creatinine Concentration3 months1258.78 mg/24hStandard Deviation 680.31
Veg+PlaUrinary Creatinine Concentration3 months1034.3 mg/24hStandard Deviation 220.92
Veg+PlaUrinary Creatinine Concentration6 months941.71 mg/24hStandard Deviation 114.46
Veg+PlaUrinary Creatinine ConcentrationBaseline1235.99 mg/24hStandard Deviation 233.05
Veg+SupplUrinary Creatinine ConcentrationBaseline1254.65 mg/24hStandard Deviation 243.38
Veg+SupplUrinary Creatinine Concentration6 months1090.67 mg/24hStandard Deviation 235.57
Veg+SupplUrinary Creatinine Concentration3 months1279.41 mg/24hStandard Deviation 215.92
Secondary

Capillary Lactate

capillary lactate at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlCapillary LactateBaseline - start1.9 mmol/LStandard Deviation 0.5
ControlCapillary LactateBaseline - end10.7 mmol/LStandard Deviation 1.6
ControlCapillary Lactate3 months - start2.4 mmol/LStandard Deviation 1
ControlCapillary Lactate3 months - end11.4 mmol/LStandard Deviation 2.6
ControlCapillary Lactate6 months - start2.0 mmol/LStandard Deviation 0.5
ControlCapillary Lactate6 months - end12.1 mmol/LStandard Deviation 2
Veg+PlaCapillary Lactate6 months - end12.7 mmol/LStandard Deviation 1.1
Veg+PlaCapillary LactateBaseline - start2.0 mmol/LStandard Deviation 0.7
Veg+PlaCapillary Lactate3 months - end14.1 mmol/LStandard Deviation 2.1
Veg+PlaCapillary Lactate6 months - start1.7 mmol/LStandard Deviation 0.4
Veg+PlaCapillary LactateBaseline - end12.4 mmol/LStandard Deviation 4.2
Veg+PlaCapillary Lactate3 months - start2.0 mmol/LStandard Deviation 0.9
Veg+SupplCapillary LactateBaseline - end10.7 mmol/LStandard Deviation 2.7
Veg+SupplCapillary Lactate3 months - start2.2 mmol/LStandard Deviation 0.9
Veg+SupplCapillary Lactate6 months - end13.1 mmol/LStandard Deviation 2.1
Veg+SupplCapillary Lactate3 months - end12.2 mmol/LStandard Deviation 2.3
Veg+SupplCapillary LactateBaseline - start1.8 mmol/LStandard Deviation 0.8
Veg+SupplCapillary Lactate6 months - start2.2 mmol/LStandard Deviation 1.1
Secondary

Capillary pH

capillary pH at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlCapillary pHBaseline - start7.4 pHStandard Deviation 0.02
ControlCapillary pHBaseline - end7.28 pHStandard Deviation 0.03
ControlCapillary pH3 months - start7.4 pHStandard Deviation 0.03
ControlCapillary pH3 months - end7.27 pHStandard Deviation 0.04
ControlCapillary pH6 months - start7.42 pHStandard Deviation 0.04
ControlCapillary pH6 months - end7.29 pHStandard Deviation 0.05
Veg+PlaCapillary pH6 months - end7.27 pHStandard Deviation 0.03
Veg+PlaCapillary pHBaseline - start7.41 pHStandard Deviation 0.02
Veg+PlaCapillary pH3 months - end7.23 pHStandard Deviation 0.04
Veg+PlaCapillary pH6 months - start7.43 pHStandard Deviation 0.02
Veg+PlaCapillary pHBaseline - end7.24 pHStandard Deviation 0.07
Veg+PlaCapillary pH3 months - start7.42 pHStandard Deviation 0.03
Veg+SupplCapillary pHBaseline - end7.28 pHStandard Deviation 0.06
Veg+SupplCapillary pH3 months - start7.41 pHStandard Deviation 0.01
Veg+SupplCapillary pH6 months - end7.28 pHStandard Deviation 0.04
Veg+SupplCapillary pH3 months - end7.26 pHStandard Deviation 0.04
Veg+SupplCapillary pHBaseline - start7.42 pHStandard Deviation 0.02
Veg+SupplCapillary pH6 months - start7.43 pHStandard Deviation 0.01
Secondary

Time to Exhaustion

Time to exhaustion during incremental cycling test performed at 0, 3 and 6 months

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlTime to ExhaustionBaseline14.5 minutesStandard Deviation 1.9
ControlTime to Exhaustion3 months14.0 minutesStandard Deviation 3
ControlTime to Exhaustion6 months14.6 minutesStandard Deviation 2.2
Veg+PlaTime to ExhaustionBaseline15.1 minutesStandard Deviation 2.7
Veg+PlaTime to Exhaustion3 months14.7 minutesStandard Deviation 2.5
Veg+PlaTime to Exhaustion6 months15.0 minutesStandard Deviation 2.5
Veg+SupplTime to ExhaustionBaseline13.8 minutesStandard Deviation 2.6
Veg+SupplTime to Exhaustion3 months13.6 minutesStandard Deviation 2.4
Veg+SupplTime to Exhaustion6 months13.8 minutesStandard Deviation 2.9
Secondary

Urinary Biomarker for Meat Intake: Anserine

urinary anserine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlUrinary Biomarker for Meat Intake: Anserine3 months9.5 mg/24hStandard Deviation 7.4
ControlUrinary Biomarker for Meat Intake: AnserineBaseline15.0 mg/24hStandard Deviation 14.3
ControlUrinary Biomarker for Meat Intake: Anserine6 months11.6 mg/24hStandard Deviation 23.2
Veg+PlaUrinary Biomarker for Meat Intake: Anserine3 months5.5 mg/24hStandard Deviation 2.9
Veg+PlaUrinary Biomarker for Meat Intake: AnserineBaseline9.2 mg/24hStandard Deviation 7.9
Veg+PlaUrinary Biomarker for Meat Intake: Anserine6 months4.0 mg/24hStandard Deviation 1.9
Veg+SupplUrinary Biomarker for Meat Intake: AnserineBaseline10.7 mg/24hStandard Deviation 12.9
Veg+SupplUrinary Biomarker for Meat Intake: Anserine6 months2.6 mg/24hStandard Deviation 1.1
Veg+SupplUrinary Biomarker for Meat Intake: Anserine3 months4.4 mg/24hStandard Deviation 2.2
Secondary

Urinary Biomarker for Meat Intake: Pi-methyl-histidine

urinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlUrinary Biomarker for Meat Intake: Pi-methyl-histidine3 months117.8 mg/24hStandard Deviation 124.8
ControlUrinary Biomarker for Meat Intake: Pi-methyl-histidineBaseline161.9 mg/24hStandard Deviation 111.2
ControlUrinary Biomarker for Meat Intake: Pi-methyl-histidine6 months122.5 mg/24hStandard Deviation 168.8
Veg+PlaUrinary Biomarker for Meat Intake: Pi-methyl-histidine3 months26.4 mg/24hStandard Deviation 10.7
Veg+PlaUrinary Biomarker for Meat Intake: Pi-methyl-histidineBaseline167.4 mg/24hStandard Deviation 145.3
Veg+PlaUrinary Biomarker for Meat Intake: Pi-methyl-histidine6 months15.1 mg/24hStandard Deviation 4.7
Veg+SupplUrinary Biomarker for Meat Intake: Pi-methyl-histidineBaseline212.9 mg/24hStandard Deviation 201
Veg+SupplUrinary Biomarker for Meat Intake: Pi-methyl-histidine6 months18.0 mg/24hStandard Deviation 6.7
Veg+SupplUrinary Biomarker for Meat Intake: Pi-methyl-histidine3 months28.7 mg/24hStandard Deviation 9.1
Secondary

Urinary Biomarker for Meat Intake: Tau-methyl-histidine

urinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlUrinary Biomarker for Meat Intake: Tau-methyl-histidine3 months74.6 mg/24hStandard Deviation 61.6
ControlUrinary Biomarker for Meat Intake: Tau-methyl-histidineBaseline55.2 mg/24hStandard Deviation 25.3
ControlUrinary Biomarker for Meat Intake: Tau-methyl-histidine6 months42.6 mg/24hStandard Deviation 21.5
Veg+PlaUrinary Biomarker for Meat Intake: Tau-methyl-histidine3 months43.1 mg/24hStandard Deviation 15.3
Veg+PlaUrinary Biomarker for Meat Intake: Tau-methyl-histidineBaseline63.1 mg/24hStandard Deviation 20
Veg+PlaUrinary Biomarker for Meat Intake: Tau-methyl-histidine6 months27.6 mg/24hStandard Deviation 7.1
Veg+SupplUrinary Biomarker for Meat Intake: Tau-methyl-histidineBaseline63.0 mg/24hStandard Deviation 22.3
Veg+SupplUrinary Biomarker for Meat Intake: Tau-methyl-histidine6 months26.5 mg/24hStandard Deviation 8.5
Veg+SupplUrinary Biomarker for Meat Intake: Tau-methyl-histidine3 months46.1 mg/24hStandard Deviation 16
Secondary

Vitamin D Status

Serum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlVitamin D Status3 months24.9 ng/mlStandard Deviation 10
ControlVitamin D StatusBaseline32.7 ng/mlStandard Deviation 13.6
ControlVitamin D Status6 months34.6 ng/mlStandard Deviation 14.1
Veg+PlaVitamin D Status3 months22.7 ng/mlStandard Deviation 9
Veg+PlaVitamin D StatusBaseline29.1 ng/mlStandard Deviation 10.3
Veg+PlaVitamin D Status6 months30.1 ng/mlStandard Deviation 10.8
Veg+SupplVitamin D StatusBaseline29.8 ng/mlStandard Deviation 8.9
Veg+SupplVitamin D Status6 months31.1 ng/mlStandard Deviation 9.1
Veg+SupplVitamin D Status3 months24.6 ng/mlStandard Deviation 7.8
Secondary

VO2max

VO2max during incremental cycling test performed at 0, 3 and 6 months

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlVO2max3 months39.0 ml/min/kgStandard Deviation 8.8
ControlVO2maxBaseline40.4 ml/min/kgStandard Deviation 6.4
ControlVO2max6 months39.4 ml/min/kgStandard Deviation 6.9
Veg+PlaVO2max3 months37.8 ml/min/kgStandard Deviation 8
Veg+PlaVO2maxBaseline39.4 ml/min/kgStandard Deviation 6.4
Veg+PlaVO2max6 months38.1 ml/min/kgStandard Deviation 6.6
Veg+SupplVO2maxBaseline36.6 ml/min/kgStandard Deviation 6.3
Veg+SupplVO2max6 months34.5 ml/min/kgStandard Deviation 4.9
Veg+SupplVO2max3 months34.8 ml/min/kgStandard Deviation 4.7

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026