Creatine, Carnitine and Carnosine in Vegetarians

NCT03194334 | Completed Results

• 1 other identifier: EC/2012/666
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dietary Modification

Keywords

vegetarianism; creatine; carnosine; carnitine

Outcome Measures

Primary Outcomes (14)

• Fasted Plasma Beta-alanine Concentration

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

  6 months

• Gastrocnemius Carnosine Concentration

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

  6 months

• Soleus Carnosine Concentration

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

  6 months

• Plasma Creatine Concentration

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

  6 months

• Plasma Creatinine Concentration

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

  6 months

• Plasma Guanidinoacetate Concentration

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

  6 months

• Urinary Creatinine Concentration

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

  6 months

• Muscle Creatine Concentration

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

  3 months

• Plasma Carnitine Concentration

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

  6 months

• Plasma Acetylcarnitine Concentration

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

  6 months

• Plasma Total Carnitine Concentration

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

  6 months

• Muscle Carnitine Concentration

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

  3 months

• Muscle Acetylcarnitine Concentration

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

  3 months

• Muscle Total Carnitine Concentration

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

  3 months

Secondary Outcomes (8)

• Vitamin D Status

  6 months

• Urinary Biomarker for Meat Intake: Pi-methyl-histidine

  6 months

• Urinary Biomarker for Meat Intake: Tau-methyl-histidine

  6 months

• Urinary Biomarker for Meat Intake: Anserine

  6 months

• VO2max

  6 months

Study Arms (3)

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

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

Behavioral: Vegetarian diet; Dietary Supplement: creatine; Dietary Supplement: Beta-alanine

Interventions

Vegetarian diet BEHAVIORAL

Also known as: lacto-ovo-vegetarian diet

Veg+ creatine and beta-alanine; Veg+Pla

creatine DIETARY_SUPPLEMENT

1g creatine/day

Veg+ creatine and beta-alanine

Placebo DIETARY_SUPPLEMENT

pills

Veg+Pla

Beta-alanine DIETARY_SUPPLEMENT

0.8g beta-alanine per day

Veg+ creatine and beta-alanine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Related Publications (2)

• 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.

  PMID: 31593541 DERIVED

• Blancquaert 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.

  PMID: 29569535 DERIVED

MeSH Terms

Interventions

Diet, Vegetarian; Creatine; beta-Alanine

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Alanine

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof. Wim Derave
• Organization: University Ghent

wim.derave@ugent.be

+32/9/2646326

Study Officials

• Wim Derave, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 21, 2017
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share