Dietary Modification Clinical Trial
Official title:
Effect of a 6-month Vegetarian Diet in Omnivorous Women on Body Creatine, Carnitine and Carnosine Stores
NCT number | NCT03194334 |
Other study ID # | EC/2012/666 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2012 |
Est. completion date | June 2013 |
Verified date | October 2018 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Gastrocnemius Carnosine Concentration | Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Soleus Carnosine Concentration | Soleus carnosine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Plasma Creatine Concentration | Plasma creatine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Plasma Creatinine Concentration | Plasma creatinine at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Plasma Guanidinoacetate Concentration | Plasma guanidinoacetate at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Urinary Creatinine Concentration | Urinary creatinine at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Muscle Creatine Concentration | Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention | 3 months | |
Primary | Plasma Carnitine Concentration | plasma free carnitine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Plasma Acetylcarnitine Concentration | plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Plasma Total Carnitine Concentration | plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention | 6 months | |
Primary | Muscle Carnitine Concentration | muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention | 3 months | |
Primary | Muscle Acetylcarnitine Concentration | muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention | 3 months | |
Primary | 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 | Vitamin D Status | Serum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention | 6 months | |
Secondary | Urinary Biomarker for Meat Intake: Pi-methyl-histidine | urinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Secondary | Urinary Biomarker for Meat Intake: Tau-methyl-histidine | urinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Secondary | Urinary Biomarker for Meat Intake: Anserine | urinary anserine concentration at 0, 3 and 6 months of the intervention | 6 months | |
Secondary | VO2max | VO2max during incremental cycling test performed at 0, 3 and 6 months | 6 months | |
Secondary | Time to Exhaustion | Time to exhaustion during incremental cycling test performed at 0, 3 and 6 months | 6 months | |
Secondary | Capillary Lactate | capillary lactate at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months | 6 months | |
Secondary | Capillary pH | capillary pH at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months | 6 months |
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