Does Co-administration of Lactate Affect Postprandial Nutrient Absorption and Fat Disposition?
NCT ID: NCT06668714
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2024-08-22
2026-01-31
Brief Summary
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Hypothesis The addition of lactate to a meal improves postprandial lipemia and reduces lipid storage in ectopic tissues through delayed absorption and faster removal of circulating lipids from circulation.
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Detailed Description
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To address these potential effects, the investigators aim to implement and validate a new tracer method in Denmark to measure meal fat partitioning using an orally ingested fluorine-labeled fatty acid analog (18F-fluoro-6-thiaheptadecanoic acid, 18F-FTHA) combined with positron emission tomography coupled to computed tomography (PET-CT). In a previous study using the aforementioned method, it has been shown that individuals with an impaired glucose tolerance have increased myocardial fatty acid uptake, not explained by potential confounding factors and that this is associated with a reduced systolic ejection fraction. In a recent study, it was found that subjects with insulin resistance have a higher uptake of free fatty acids in visceral adipose tissue compared with subjects without insulin resistance.
This method will enable the investigators to determine how the addition of lactate to a test meal will affect meal fat partitioning. Previous methods for determining fatty acid partitioning and accumulation have either been limited to only determining the accumulation in non-oxidative tissues or very invasive or difficult to perform, making this the first method to non-invasively simultaneously measure the partitioning of meal fatty acids in all human organs.
Work package 1 (WP1):
The investigators will also include 8 healthy individuals (HbA1c mmol/mol\< 39, age 50+ years) as a healthy control group, who will be studied twice in a randomized trial following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.
Work package 2 (WP2):
In a randomized, double-blinded placebo-controlled crossover trial, the investigators will investigate the effect of 25 g lactate vs. placebo prior to a liquid test meal, with the addition of 18F-FTHA, on two trial days separated by a minimum of seven days and a maximum of one month. The investigators will include 16 individuals with pre-diabetes (HbA1c 39-47 mmol/mol) and from 50+ years of age.
In a WP3 we will include one healthy participant who will receive 18F-FTHA with water instead of a mixed meal, to evaluate if the tracer can be used for diagnostics of lesions of the thoracic duct when given with water.
The investigators will use paired t-tests analyses for comparing CTR and LAC and independent t-test samples for comparing the individuals with pre-diabetes and the healthy individuals.
Based on the results from a previous study using 18F-FTHA-PET, the investigators will need to include 15 individuals to detect a 15% decrease in meal fat uptake in the heart (α=0.05, β=0.80). To account for potential missing values or failed PET-CT scans, the investigators will include a total of 16 individuals.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo pre-diabetes
Placebo + mixed meal
Placebo (140 mL isoosmotic salt water, NaCl) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = CTR
Lactate + mixed meal
Lactate (140 mL lactate drink = 25 g D/L-lactate bound to Na) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = LAC The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.
PET-scan
Dynamic whole-body PET scan.
Lactate pre-diabetes
Placebo + mixed meal
Placebo (140 mL isoosmotic salt water, NaCl) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = CTR
Lactate + mixed meal
Lactate (140 mL lactate drink = 25 g D/L-lactate bound to Na) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = LAC The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.
PET-scan
Dynamic whole-body PET scan.
Healthy
We will include 8 healthy, normal-weight individuals (BMI 20-25 kg/m2, age 50+ years) as a healthy control group, who will be studied twice following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.
PET-scan
Dynamic whole-body PET scan.
Mixed meal with 18F-FTHA
Mixed meal test with the addition of 70 MBq 18F-FTHA
Interventions
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Placebo + mixed meal
Placebo (140 mL isoosmotic salt water, NaCl) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = CTR
Lactate + mixed meal
Lactate (140 mL lactate drink = 25 g D/L-lactate bound to Na) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = LAC The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.
PET-scan
Dynamic whole-body PET scan.
Mixed meal with 18F-FTHA
Mixed meal test with the addition of 70 MBq 18F-FTHA
Eligibility Criteria
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Inclusion Criteria
* Written and oral consent
* HbA1c 39-47 mmol/L
Exclusion Criteria
* Newly started medicine (\&lt;3 months prior to the inclusion time)
* Medicine changes (\&lt;3 months prior to the inclusion time and planned changes during the trial)
* Affected screening blood sample as evaluated by PI
* Hba1c \> 47
* Allergy to paracetamol
* Doesn't speak or understand Danish
* Special diets
The eight healthy individuals will be included by the same criteria except for not having pre-diabetes
50 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Natasa Brkovic Zubanovic
Principal Investigator
Principal Investigators
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Esben Søndergaard
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Steno Diabetes Center Aarhus
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAMETA-PET
Identifier Type: -
Identifier Source: org_study_id
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