Appetitive BehaviorNCT06379815
Effect of Oral Lactate Ingestion on Appetite Regulation
A study testing Sodium Lactate and Sodium Chloride in people with Appetitive Behavior, run by Wilfrid Laurier University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Sodium Lactate and Sodium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire
- Female participants must be eumenorrheic (menstrual cycle length between 21-35 days)
Who cannot join
- 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,
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Appetitive Behavior
- Being tested
- Sodium Lactate, Sodium Chloride
- Keywords
- lactate, appetite regulation, acylated ghrelin, energy intake
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium LactateOther
See arm/group description.
Sodium ChlorideOther
See arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lactate
Lactate measured in blood.
Measured: 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.
Measured: 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.
Measured: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Secondary outcomes (2)
Subjective appetite perception
Measured using visual analogue scale
Measured: 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
Measured: Day 1 (day before the experimental session), Day 2 (day of the experimental session), and Day 3 (day after the experimental session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Tom Hazell, Wilfrid Laurier University
- Investigators
- Tom J Hazell, PhD, Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379815
- Sponsor's protocol ID
- EMRL-23-03
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCarthy SF, Bornath DPD, Tucker JAL, Hazell TJ. Oral sodium lactate ingestion does not increase blood lactate concentrations and is accompanied by moderate-to-severe gastrointestinal side effects. J Appl Physiol (1985). 2024 Nov 1;137(5):1279-1284. doi: 10.1152/japplphysiol.00536.2024. Epub 2024 Sep 12.
PubMed 39262340
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Lactate Ingestion on Appetite Regulation
- ClinicalTrials.gov ID
- NCT06379815
- Acronym / sponsor ID
- EMRL-23-03
- Conditions
- Appetitive Behavior
- Keywords
- lactate, appetite regulation, acylated ghrelin, energy intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Sodium Lactate | Experimental | Other: Sodium LactateParticipants 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. |
| Sodium Chloride | Placebo comparator | Other: Sodium ChlorideParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire
- Female participants must be eumenorrheic (menstrual cycle length between 21-35 days)
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium LactateSee arm/group description. | Other | Sodium Lactate |
| Sodium ChlorideSee arm/group description. | Other | Sodium Chloride |
Primary outcome
Blood Lactate
Time frame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Lactate measured in blood.
Acylated ghrelin
Time frame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Acylated ghrelin measured in blood via ELISA.
Total ghrelin
Time frame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Total ghrelin measured in blood via ELISA.
2 secondary outcomes
Subjective appetite perception
Time frame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.
Free-living energy intake
Time frame: Day 1 (day before the experimental session), Day 2 (day of the experimental session), and Day 3 (day after the experimental session).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 39262340McCarthy SF, Bornath DPD, Tucker JAL, Hazell TJ. Oral sodium lactate ingestion does not increase blood lactate concentrations and is accompanied by moderate-to-severe gastrointestinal side effects. J Appl Physiol (1985). 2024 Nov 1;137(5):1279-1284. doi: 10.1152/japplphysiol.00536.2024. Epub 2024 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom J Hazell, PhD principal investigator
Wilfrid Laurier University
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Lactate and Sodium Chloride in people with Appetitive Behavior, run by Wilfrid Laurier University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom J Hazell, PhD (5488893902, thazell@wlu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Lactate (time frame: Pre-ingestion, 30 minutes following ingestion, 45 minutes following ingestion, 60 minutes following ingestion, and 90minutes following ingestion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.