Long-Term Effect of Combined Citrulline and Nitrate-Rich Beetroot Extract Supplementation

Sponsor

Burgos Nutrition (Other)

Overall Status

Completed

CT.gov ID

NCT05143879

Collaborator

Universidad de León (Other), University of the Basque Country (UPV/EHU) (Other), University of Valladolid (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been investigated to date. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone, cortisol and Testosterone cortisol ratio (T/C)) in male trained triathletes. This study was a double-blind, placebo-controlled trial where participants (n = 32) were randomized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8). Blood samples were collected from all participants at baseline (T1) and after 9 weeks of supplementation (T2).

Condition or Disease	Intervention/Treatment	Phase
Citrulline Nitrate Athletes	Dietary Supplement: Citrulline Dietary Supplement: Nitrate Dietary Supplement: Nitrate plus Citrulline Dietary Supplement: Placebo	N/A

Detailed Description

Triathlon is an endurance sport in which athletes compete sequentially in swimming, cycling and running. Prolonged and strenuous training combined with insufficient recovery can produce muscular and metabolic stress, resulting in structural and functional damage to the musculoskeletal system leading to a fatigue status, which results in decreased athletic performance. As a consequence of this type of combined exercise, there are also alterations in biochemical markers of exercise-induced muscle damage (EIMD) as well as anabolic/catabolic hormones. Therefore, their analysis is useful in determining the balance between training loads and recovery. In this sense, it is essential to include different strategies to reduce or prevent EIMD, which delay or reduce muscle fatigue and improve sports performance. One of these strategies is the use of different ergogenic aids such as L-citrulline (CIT) and nitrates (NIT) which have been proposed as both substances produce an increase in nitric oxide (NO).

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

The main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CM plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone (T), cortisol (C), and T/C) in male trained triathletes.The main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CM plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone (T), cortisol (C), and T/C) in male trained triathletes.

Masking:

Single (Investigator)

Masking Description:

This study was a double-blind, placebo-controlled trial where participants (n = 32) were random-ized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8)

Primary Purpose:

Other

Official Title:

Long-term Effect of Combined Citrulline and Nitrate-rich Beetroot Extract Supplementation on Recovery Status in Trained Male Triathletes

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Aug 30, 2018

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 8 subjects took 3 g/kg/day of placebo during 9 weeks	Dietary Supplement: Placebo 3 g/day during 9 weeks Other Names: Cellulose
Active Comparator: Nitrate 8 subjects took 3 g/kg/day of nitrate during 9 weeks	Dietary Supplement: Nitrate 300 mg/day during 9 weeks
Active Comparator: Citrulline 8 subjects took 3 g/kg/day of citrulline during 9 weeks	Dietary Supplement: Citrulline 3 g/day during 9 weeks
Active Comparator: Nitrate plus Citrulline 8 subjects took 3 g/kg/day of nitrate plus citrulline during 9 weeks	Dietary Supplement: Nitrate plus Citrulline 3 g/day of citrulline and 300 mg/day of nitrate during 9 weeks

Outcome Measures

Primary Outcome Measures

Cortisol [9 weeks]
μg/dL
Testosterone [9 weeks]
ng/mL
Testosterone to cortisol ratio [9 weeks]
ng/mL
Urea [9 weeks]
mg/dl
Creatinine [9 weeks]
mg/dl
AST [9 weeks]
U/L
ALT [9 weeks]
U/L
GGT [9 weeks]
U/L
LDH [9 weeks]
U/L
CK [9 weeks]
U/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males between 25 and 35 years old
Triathletes
With at least 5 years of experience
Without any disease
Non smokers
Non drinkers of alcohol
Not to take any other medications or stimulant substances during the study
2 weeks without taking other nutritional supplements

Exclusion Criteria:

Exclusion criteria:
Men under 25 and over 35 years of age.
Non triathletes
Less than 5 years of experience
With any disease
Smokers
Alcohol drinkers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Leon	León	Castilla Y León	Spain	24004

Sponsors and Collaborators

Burgos Nutrition
Universidad de León
University of the Basque Country (UPV/EHU)
University of Valladolid

Investigators

Principal Investigator: Jose Burgos Balmaseda, Graduate, University of Leon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Burgos Balmaseda, Principal investigator, Burgos Nutrition

ClinicalTrials.gov Identifier:

NCT05143879

Other Study ID Numbers:

ULE-020-2020

First Posted:

Dec 3, 2021

Last Update Posted:

Dec 3, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Jose Burgos Balmaseda, Principal investigator, Burgos Nutrition

Study Results

No Results Posted as of Dec 3, 2021