Clinical trial NCT06379815: Effect of Oral Lactate Ingestion on Appetite Regulation
Official title: Effect of Oral Lactate Ingestion on Appetite Regulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Appetitive Behavior
Keywords: lactate
appetite regulation
acylated ghrelin
energy intake
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2024-04-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The purpose of this study is to explore the effects of oral lactate ingestion on appetite regulation in humans. To do this males and females will report to the laboratory for 2 experimental sessions completed in a counterbalanced, double-blinded manner. During one session a lactate solution will be ingested, in another session an equimolar sodium chloride solution will be ingested that matches the osmolarity of the lactate condition. Venous blood samples and subjective appetite perceptions will be obtained at five time points during each experimental session. Energy expenditure will be measured through accelerometers placed on the participants anterior thigh by an investigator on the morning the day before the session and worn over the experimental period (day before, day of, day after) recording their physical activity. Energy intake will be tracked using a smartphone mobile application called Keenoa over the same time period the accelerometers are worn.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Failure to meet inclusion criteria
* 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,

Primary outcomes:
measure: Blood Lactate
timeFrame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
measure: Acylated ghrelin
timeFrame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
measure: Total ghrelin
timeFrame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Secondary outcomes:
measure: Subjective appetite perception
timeFrame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
measure: Free-living energy intake
timeFrame: Day 1 (day before the experimental session), Day 2 (day of the experimental session), and Day 3 (day after the experimental session).
Other outcomes:
Locations:
Study officials:
affiliation: Wilfrid Laurier University
name: Tom J Hazell, PhD
role: PRINCIPAL_INVESTIGATOR
References: