Effect of Oral Lactate Ingestion on Appetite Regulation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Appetitive Behavior
• Intervention / Treatment: Other: Sodium Lactate; Other: Sodium Chloride

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom J Hazell, PhD; Phone Number: 5488893902; Email: thazell@wlu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Lactate; 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; See arm/group description.
Placebo Comparator: Sodium Chloride; 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; See arm/group description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite perception	Measured using visual analogue scale	Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Free-living energy intake	Free-living energy intake measured using a mobile application Keenoa	Day 1 (day before the experimental session), Day 2 (day of the experimental session), and Day 3 (day after the experimental session).

Collaborators and Investigators

• Sponsor: Wilfrid Laurier University
• Collaborators: Natural Sciences and Engineering Research Council, Canada
• Investigators: Principal Investigator: Tom J Hazell, PhD, Wilfrid Laurier University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: energy intake; lactate; appetite regulation; acylated ghrelin
• Other Study ID Numbers: EMRL-23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No