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Creatine, Carnitine and Carnosine in Vegetarians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194334
Recruitment Status : Completed
First Posted : June 21, 2017
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Ghent

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Dietary Modification
Interventions Behavioral: Vegetarian diet
Dietary Supplement: creatine
Dietary Supplement: Placebo
Dietary Supplement: Beta-alanine
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description continued their omnivorous diet throughout the entire study

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

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

Period Title: 0-3 Months
Started 10 15 15
Completed 10 15 14
Not Completed 0 0 1
Period Title: 3-6 Months
Started 10 15 14
Completed 10 15 14
Not Completed 0 0 0
Arm/Group Title Control Veg+Pla Veg+Suppl Total
Hide Arm/Group Description continued their omnivorous diet throughout the entire study

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

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

Total of all reporting groups
Overall Number of Baseline Participants 10 15 15 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 15 participants 15 participants 40 participants
25.9  (9) 26.1  (7.5) 25.5  (6.6) 25.6  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 15 participants 40 participants
Female
10
 100.0%
15
 100.0%
15
 100.0%
40
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 15 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
10
 100.0%
15
 100.0%
15
 100.0%
40
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Belgium Number Analyzed 10 participants 15 participants 15 participants 40 participants
10
 100.0%
15
 100.0%
15
 100.0%
40
 100.0%
1.Primary Outcome
Title Fasted Plasma Beta-alanine Concentration
Hide Description Fasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µM
Basline 3.37  (1.96) 5.19  (2.26) 4.56  (2.74)
3 months 3.76  (2.58) 5.11  (1.99) 5.8  (3.24)
6 months 3.9  (2.88) 5.59  (2.63) 5.42  (3.99)
2.Primary Outcome
Title Gastrocnemius Carnosine Concentration
Hide Description Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+ Creatine and Beta-alanine
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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: 1g creatine/day

Beta-alanine: 0.8g beta-alanine per day

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mM
Baseline 5.18  (1.21) 5.16  (1.46) 5.1  (1.61)
3 months 5.58  (0.97) 5.55  (1.4) 6.55  (1.53)
6 months 5.68  (1.07) 5.81  (1.82) 7.19  (2.11)
3.Primary Outcome
Title Soleus Carnosine Concentration
Hide Description Soleus carnosine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mM
Baseline 3.91  (0.43) 3.53  (0.94) 3.7  (1.08)
3 months 3.84  (0.74) 3.36  (0.97) 4.72  (1.11)
6 months 4.0  (0.72) 3.65  (1.38) 4.67  (1.38)
4.Primary Outcome
Title Plasma Creatine Concentration
Hide Description Plasma creatine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 35.7  (19.8) 29.7  (15.3) 27.3  (9.6)
3 months 28.1  (11.9) 15.8  (10.0) 56.9  (36.3)
6 months 40.6  (21.6) 16.1  (7.9) 80.7  (65.7)
5.Primary Outcome
Title Plasma Creatinine Concentration
Hide Description Plasma creatinine at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 97.33  (7.8) 79.49  (29.09) 79.9  (15.83)
3 months 96.62  (15.1) 85.68  (30.94) 78.47  (17.8)
6 months 96.18  (17.5) 75.41  (26.35) 88.13  (17.09)
6.Primary Outcome
Title Plasma Guanidinoacetate Concentration
Hide Description Plasma guanidinoacetate at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 2.23  (0.49) 2.06  (0.59) 1.95  (0.52)
3 months 2.2  (0.55) 2.05  (0.63) 1.87  (0.72)
6 months 2.42  (0.92) 2.0  (0.63) 1.75  (0.67)
7.Primary Outcome
Title Urinary Creatinine Concentration
Hide Description Urinary creatinine at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mg/24h
Baseline 1298.62  (269.46) 1235.99  (233.05) 1254.65  (243.38)
3 months 1258.78  (680.31) 1034.3  (220.92) 1279.41  (215.92)
6 months 990.25  (298.77) 941.71  (114.46) 1090.67  (235.57)
8.Primary Outcome
Title Muscle Creatine Concentration
Hide Description Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mmol/kg
Baseline 133.2  (11.6) 153.5  (24.0) 128.2  (14.9)
3 months 142.2  (12.7) 128.8  (11.6) 140.7  (17.4)
9.Primary Outcome
Title Plasma Carnitine Concentration
Hide Description plasma free carnitine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 30.81  (6.6) 29.82  (4.45) 28.39  (6.38)
3 months 28.7  (6.11) 26.45  (6.21) 25.71  (6.22)
6 months 31.71  (6.75) 28.23  (4.88) 27.31  (7.8)
10.Primary Outcome
Title Plasma Acetylcarnitine Concentration
Hide Description plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 8.49  (2.24) 7.71  (1.95) 8.09  (1.98)
3 months 6.82  (1.31) 6.93  (1.78) 6.77  (1.33)
6 months 7.15  (1.41) 7.54  (1.67) 7.15  (3.16)
11.Primary Outcome
Title Plasma Total Carnitine Concentration
Hide Description plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 41.58  (6.97) 40.85  (7.42) 40.24  (5.75)
3 months 37.96  (6.44) 36.16  (7.83) 35.9  (5.48)
6 months 41.25  (8.02) 38.58  (6.45) 37.87  (9.51)
12.Primary Outcome
Title Muscle Carnitine Concentration
Hide Description muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mmol/kg dry weight
Baseline 13.1  (4.0) 12.1  (4.1) 10.7  (2.8)
3 months 11.5  (2.9) 11.5  (4.9) 9.7  (3.2)
13.Primary Outcome
Title Muscle Acetylcarnitine Concentration
Hide Description muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mmol/kg dry weight
Baseline 3.3  (3.2) 4.2  (2.4) 3.3  (2.9)
3 months 3.6  (1.9) 3.5  (4.1) 3.2  (2.5)
14.Primary Outcome
Title Muscle Total Carnitine Concentration
Hide Description muscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mmol/kg dry weight
Baseline 16.5  (2.4) 16.3  (3.5) 13.9  (2.3)
3 months 15.5  (3.2) 13.6  (2.3) 12.7  (2.2)
15.Secondary Outcome
Title Vitamin D Status
Hide Description Serum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: ng/ml
Baseline 32.7  (13.6) 29.1  (10.3) 29.8  (8.9)
3 months 24.9  (10.0) 22.7  (9.0) 24.6  (7.8)
6 months 34.6  (14.1) 30.1  (10.8) 31.1  (9.1)
16.Secondary Outcome
Title Urinary Biomarker for Meat Intake: Pi-methyl-histidine
Hide Description urinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mg/24h
Baseline 161.9  (111.2) 167.4  (145.3) 212.9  (201.0)
3 months 117.8  (124.8) 26.4  (10.7) 28.7  (9.1)
6 months 122.5  (168.8) 15.1  (4.7) 18.0  (6.7)
17.Secondary Outcome
Title Urinary Biomarker for Meat Intake: Tau-methyl-histidine
Hide Description urinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mg/24h
Baseline 55.2  (25.3) 63.1  (20.0) 63.0  (22.3)
3 months 74.6  (61.6) 43.1  (15.3) 46.1  (16.0)
6 months 42.6  (21.5) 27.6  (7.1) 26.5  (8.5)
18.Secondary Outcome
Title Urinary Biomarker for Meat Intake: Anserine
Hide Description urinary anserine concentration at 0, 3 and 6 months of the intervention
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mg/24h
Baseline 15.0  (14.3) 9.2  (7.9) 10.7  (12.9)
3 months 9.5  (7.4) 5.5  (2.9) 4.4  (2.2)
6 months 11.6  (23.2) 4.0  (1.9) 2.6  (1.1)
19.Secondary Outcome
Title VO2max
Hide Description VO2max during incremental cycling test performed at 0, 3 and 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: ml/min/kg
Baseline 40.4  (6.4) 39.4  (6.4) 36.6  (6.3)
3 months 39.0  (8.8) 37.8  (8.0) 34.8  (4.7)
6 months 39.4  (6.9) 38.1  (6.6) 34.5  (4.9)
20.Secondary Outcome
Title Time to Exhaustion
Hide Description Time to exhaustion during incremental cycling test performed at 0, 3 and 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline 14.5  (1.9) 15.1  (2.7) 13.8  (2.6)
3 months 14.0  (3.0) 14.7  (2.5) 13.6  (2.4)
6 months 14.6  (2.2) 15.0  (2.5) 13.8  (2.9)
21.Secondary Outcome
Title Capillary Lactate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline - start 1.9  (0.5) 2.0  (0.7) 1.8  (0.8)
Baseline - end 10.7  (1.6) 12.4  (4.2) 10.7  (2.7)
3 months - start 2.4  (1.0) 2.0  (0.9) 2.2  (0.9)
3 months - end 11.4  (2.6) 14.1  (2.1) 12.2  (2.3)
6 months - start 2.0  (0.5) 1.7  (0.4) 2.2  (1.1)
6 months - end 12.1  (2.0) 12.7  (1.1) 13.1  (2.1)
22.Secondary Outcome
Title Capillary pH
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description:
continued their omnivorous diet throughout the entire study

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

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

Overall Number of Participants Analyzed 10 15 14
Mean (Standard Deviation)
Unit of Measure: pH
Baseline - start 7.4  (0.02) 7.41  (0.02) 7.42  (0.02)
Baseline - end 7.28  (0.03) 7.24  (0.07) 7.28  (0.06)
3 months - start 7.4  (0.03) 7.42  (0.03) 7.41  (0.01)
3 months - end 7.27  (0.04) 7.23  (0.04) 7.26  (0.04)
6 months - start 7.42  (0.04) 7.43  (0.02) 7.43  (0.01)
6 months - end 7.29  (0.05) 7.27  (0.03) 7.28  (0.04)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Veg+Pla Veg+Suppl
Hide Arm/Group Description continued their omnivorous diet throughout the entire study

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

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

All-Cause Mortality
Control Veg+Pla Veg+Suppl
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/15 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Veg+Pla Veg+Suppl
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/15 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Veg+Pla Veg+Suppl
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/15 (0.00%)   0/14 (0.00%) 
A far too low number of subjects consented to have muscle biopsies taken at 6M. Therefore, muscle analyses were restricted to the 0 and 3M time points.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Wim Derave
Organization: University Ghent
Phone: +32/9/2646326
EMail: wim.derave@ugent.be
Layout table for additonal information
Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03194334     History of Changes
Other Study ID Numbers: EC/2012/666
First Submitted: June 15, 2017
First Posted: June 21, 2017
Results First Submitted: July 31, 2017
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019