NCT06379815

Brief Summary

The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet 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

April 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 12, 2024

Last Update Submit

April 17, 2024

Conditions

Keywords

lactateappetite regulationacylated ghrelinenergy intake

Outcome Measures

Primary Outcomes (3)

  • Blood Lactate

    Lactate measured in blood.

    Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.

  • Acylated ghrelin

    Acylated ghrelin measured in blood via ELISA.

    Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.

  • Total ghrelin

    Total ghrelin measured in blood via ELISA.

    Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.

Secondary Outcomes (2)

  • Subjective appetite perception

    Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.

  • Free-living energy intake

    Day 1 (day before the experimental session), Day 2 (day of the experimental session), and Day 3 (day after the experimental session).

Study Arms (2)

Sodium Lactate

EXPERIMENTAL

Participants will received 0.45 g/kg of sodium lactate (SO179, Spectrum Chemical MFG Group) mixed with water. This will be mixed at a ratio of 30 mL per g of lactate. Lemon juice is added to the mixture at a specific ratio to balance the pH of the solution. Crystal light will also be added to avoid any taste differences between beverages.

Other: Sodium Lactate

Sodium Chloride

PLACEBO COMPARATOR

Participants will receive a equimolar amount of sodium chloride (S9888, MilliporeSigma) mixed with water. The amount of water, lemon juice, and crystal light will be matched to that of the sodium lactate condition.

Other: Sodium Chloride

Interventions

See arm/group description.

Sodium Lactate

See arm/group description.

Sodium Chloride

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire
  • Female participants must be eumenorrheic (menstrual cycle length between 21-35 days)

You may not qualify if:

  • Taking supplements or medications known to affect metabolism (e.g., creatine, beta-blockers)
  • Currently pregnant or a pregnancy of \>3 months within the last 3 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Sodium LactateSodium Chloride

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Tom J Hazell, PhD

    Wilfrid Laurier University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom J Hazell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The allocation of lactate and placebo will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation. This will be completed in a counter-balanced order.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 23, 2024

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share