NCT07195240

Brief Summary

The goal of this experimental study is to examine the influence of Lemongrass extract on aerobic training parameters following a 6-week training programme in males. A secondary aim will be to explore the influence on sexual wellness. Participants will attend 23 visits to the laboratory involving:

  • fitness testing (some to exhaustion).
  • blood sampling (capillary and venous samples).
  • a supervised 6 week high-intensity interval training (HIIT) programme.
  • consuming either the lemongrass extract or placebo in the form of tablets, once a day during the 6 week training.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

October 24, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

September 5, 2025

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Aerobic Capacity

    To determine the effect of the intervention vs placebo on marker of aerobic capacity (VO2peak). It will be assessed using breath-by-breath gas analysis during a graded exercise protocol on a static bike. The test will start at the intensity immediately below the second inflection point identified on the lactate profile (conducted in visit 2). The intensity will increase by 30 w each minute until VO2peak which will be confirmed when at least one of the following criteria (according to CASES) are met: (1) a plateau in VO2 despite an increase in workload; (2) a respiratory exchange ratio (RER) higher than 1.15; (3) peak heart rate at least equal to 90% of the age-predicted maximum and/or (4) RPE of \>18; (5) a blood lactate concentration of \> 8mMol/L. Maximum aerobic power will be defined as the final completed work rate. This will be used for subsequent training prescription (125% of maximal aerobic power \[Pmax\]).

    This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).

  • Aerobic Performance (blood lactate)

    To determine the effect of intervention vs placebo on secondary markers of maximal aerobic performance (blood lactate). A total of 14 (more if the submaximal exercise test progresses beyond 4 stages) capillary samples will be collected for each participant during the submaximal and graded exercise tests. This will be pre-exercise, then in the final minute of each ramped stage during the submaximal test. A final lactate sample will be collected upon completion of the VO2peak test. These samples will be analysed for lactate concentration immediately using a Biosen C-line analyser before being disposed of.

    This measure will be assessed three times. Familiarisation and lactate profiling: Visit 2 (Week 0). Baseline assessment: Visit 3 (Week 1, prior to the intervention), Post-intervention assessment: Visit 23 (Week 8, within 48 hrs after the final training).

  • Aerobic Performance (heart rate)

    To determine the effect, if any, of intervention vs placebo on secondary markers of maximal aerobic performance (heart rate). Heart rate will be continuously monitored using a chest strap (Polar monitor) throughout the various exercise protocols (lactate profiling in visit 2 and 3, and the graded exercise task in visit 3 and 23).

    This measure will be assessed three times. Familiarisation and lactate profiling: Visit 2 (Week 0). Baseline assessment: Visit 3 (Week 1, prior to the intervention), Post-intervention assessment: Visit 23 (Week 8, within 48 hrs after the final training).

Secondary Outcomes (2)

  • Sexual Wellness

    This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).

  • Serum

    This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).

Study Arms (2)

Active: Lemongrass Extract

EXPERIMENTAL

Tablet containing 200mg Lemongrass extract (Mibelle).

Dietary Supplement: Active: Lemongrass

Control: Placebo

EXPERIMENTAL

Tablet containing microcrystalline cellulose.

Dietary Supplement: Control: Placebo

Interventions

Active: LemongrassDIETARY_SUPPLEMENT

200mg of lemongrass extract

Active: Lemongrass Extract
Control: PlaceboDIETARY_SUPPLEMENT

microcrystalline cellulose

Control: Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 40 and ≤ 60 years.
  • Body Mass Index (BMI) ≥ 19 and ≤ 35 kg/m2.
  • Willingness and ability to comply with the protocol in the opinion of the Investigator.
  • Judged by the Investigator to be in good health as assessed by a health screening questionnaire.
  • Currently identifies as the same biological sex as at birth.
  • Currently deemed to be between a physical activity status of sedentaryy to moderately trained (Meet World Health Organization minimum activity guidelines: Adults aged 18-64 years old completing at least 150 to 300 min moderate-intensity activity or 75-150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week).
  • Have a blood pressure \< 140/90 mmHg.

You may not qualify if:

  • A history of heart disease.
  • Any disease that might interfere with the absorption of nutrients (e.g. Chron's disease, celiac disease).
  • Recent musculoskeletal or soft tissue injury (within the last 3 months).
  • The habitual use of medication that is antihypertensive or antidiabetic medication or might inhibit the ability to complete the study participation.
  • Alcohol Intake of greater than 21 units per week.
  • A change in bodyweight of more than 3kg within the month preceding the study.
  • Currently following a weight-loss or weight-gain programme.
  • Any known bleeding disorder or reaction to withdrawal of blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

RECRUITING

Study Officials

  • Glyn Howatson

    Northumbria Univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 26, 2025

Study Start

October 24, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations