Nitrate Formulations and Exercise Performance

NCT06531070 | Completed

• 2 other identifiers: NITR 24.10.23CEAR ILD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

this study compares the acute effects of Nitrate and Nitrate plus citrulline supplementation on physical performance in recreationally trained males and females. This is a cross-over within-participant comparison design concluding three arms (i) 600 mg of Nitrate (N), ii) 600 mg Nitrate and Citrulline (NC) and (iii) Placebo (PL). Conditions N, NC and PL will be tested one week apart, considering a minimum washout period of 72 hours. Dependent variables:

• Number of completed repetitions to failure in squat using 75% of 1RM.
• Ventilatory thresholds (VT1) and (VT2) and Vo2 max from a progressive to exhaustion running test (PGT)
• Lactate post (within 1 min of having completed the PGT)
• Rating of perceived exertion (RPE) by the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT.
• Heart rate associated with VT1, VT2, and Vo2max - Heart rate maximum.
• Maximal aerobic speed (MAS): calculated from the average speed of the last 2 minutes of the PGT.
• time limit test at MAS (conducted after 15 min of having completed the PGT)

Conditions

Nitrate; Nitrate/Citrulline; Placebo

Outcome Measures

Primary Outcomes (2)

• Strength

  Ten maximum repetitions set in back squat using 75% of the previously determined maximal strength determined by the maximum amount of kg lifter in one sigulare repetitions

  Day 4, 2.5 hours after ingesting the supplement

• Maximum oxygen consumption (Vo2max)

  The highest level of oxygen determined during a progressive to exhaustion running test on a treadmill (PGT)

  through study completion up to 3 weeks

Secondary Outcomes (4)

• Ventilatory thresholds (VT1) and (VT2)

  15 minutes after completing the strength test

• lactate

  through study completion up to 3 weeks

• Heart Rate

  through study completion up to 3 weeks

• Rate of Perceived Exertion

  through study completion up to 3 weeks

Other Outcomes (1)

• Maximal Aerobic Speed

  through study completion up to 3 weeks

Study Arms (3)

Nitrate

EXPERIMENTAL

A gel providing 600 mg (9.6 mmol) of nitrate.

Dietary Supplement: Nitrate

Nitrated and citrulline

EXPERIMENTAL

A gel, providing 600mg of nitrate (9.6 mmol) and 6 g of citrulline-malate

Dietary Supplement: Nitrate

Placebo

PLACEBO COMPARATOR

Placebo in gel format providing negligible amount of nitrate

Dietary Supplement: Nitrate

Interventions

Nitrate DIETARY_SUPPLEMENT

A four-day supplementation period, separated by one week including a 3-day washout period between conditions will be applied before conducting strength and endurance assessments Days 1 to 3 the randomly assigned supplement (N, NC, or PLA) will be ingested 2 hr before a standard low-volume training session including 3 sets of 8 to 10 reps of squat and deadlift using a very light load (e.g., own body mass) and flexibility exercises following by 5 min of running at self-paced intensity rated as light (12) with the rating of perceived exertion Borg Scale. Day 4: the assigned supplement will be ingested 2.5 h before the assessments Assessment of strength and endurance will be conducted

Also known as: Nitrated and citrulline, Placebo

Nitrate; Nitrated and citrulline; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active participants with experience in resistance training performing squats and endurance running as habitual exercises
• Free from musculoskeletal limitations or injuries
• Agree not to ingest any other supplement during the study.

You may not qualify if:

• History of various metabolic conditions or diseases
• Use of a variety of medications, including but not limited to those with androgenic or anabolic effects or nutritional supplements known to affect training outcomes such as creatine, proteins, etc. within 6 weeks before the beginning of the study
• Current use of tobacco products.

Sponsors & Collaborators

• University of Greenwich: lead
• Crown Sport Nutrition: collaborator

Study Sites (1)

Sparrows Farm

Eltham, London, SE9 2BT, United Kingdom

Location

MeSH Terms

Interventions

Nitrates; Citrulline

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals; Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fernando Naclerio

  University of Greenwich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-07

Locations

GB (1)