Effect of Oral Lactate Ingestion on Appetite Regulation

Appetitive Behavior Clinical Trial

Official title:

Effect of Oral Lactate Ingestion on Appetite Regulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379815
• Other study ID #: EMRL-23-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Wilfrid Laurier University
• Contact: Tom J Hazell, PhD
• Phone: 5488893902
• Email: thazell[@]wlu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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,

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Other:
• Sodium Lactate
See arm/group description.
• Sodium Chloride
See arm/group description.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wilfrid Laurier University	Natural Sciences and Engineering Research Council, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Lactate	Lactate measured in blood.	Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Primary	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.
Primary	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	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.
Secondary	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).