Cardiometabolic Conditions
Conditions
Keywords
Glucagon-like peptide 1, N-acyl taurine, GPR119
Brief summary
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of arachidonoyl-taurine (C20:4-taurine) and oleoyl-taurine (C18:1-taurine) on GLP-1 secretion during fasting and feeding.
Interventions
OTHERPlacebo: First dose at 0 hours
Vehicle (ultrapure water with 10 % fish sauce), orally administered
OTHERArachidonoyl-taurine: First dose at 0 hours
Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
OTHEROleoyl-taurine: First dose at 0 hours
Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
OTHERLiquid meal and second dose of placebo at 3 hours
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Vehicle (ultrapure water with 10 % fish sauce), orally administered
OTHERLiquid meal and second dose of OLE-T at 3 hours
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
OTHERLiquid meal and second dose of ARA-T at 3 hours
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
Sponsors
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 45 years * Body mass index between 18.5-27 kg/m2 * Informed consent * Weight stable in the past 3 months
Exclusion criteria
* Regular tobacco smoking or use of other nicotine-containing products * Allergy or intolerance to ingredients included in the test compounds or standardised meals * Glycated haemoglobin (HbA1c) \>48 mmol/mol * Anaemia (haemoglobin below 8.3 mmol/L) * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times upper normal values (Normal values: ALT \< 70 U/L, AST \<45 U/L) * Nephropathy (eGFR\<90mL/min/1.73 m2) and/or albuminuria (\>30 mg/g albumin in urine)) * Women of childbearing potential who are not using effective contraception * Pregnancy or breastfeeding * History of hepatobiliary or gastrointestinal disorder(s) * Use of weight loss medication within the last 6 months * Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucagon-like peptide 1 | 0-360 minutes | Incremental area under curve 0-360 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucagon-like peptide 1 | 0-360 minutes | Difference in plasma concentration between interventions |
| Gastric inhibitory polypeptide | 0-360 minutes | Difference in plasma concentration between interventions |
| C-peptide | 0-360 minutes | Difference in plasma concentration between interventions |
| Glucagon | 0-360 minutes | Difference in plasma concentration between interventions |
| N-acyl taurine species | 0-360 minutes | Difference in plasma concentration between interventions |
| Glucose | 0-360 minutes | Difference in plasma concentration between interventions |
| Visual analogue scale | 0-360 minutes | Visual analogue scales are 10 cm long lines. Participants will score their subjective perception of their hunger, satiety, thirst, nausea and well-being from 0 cm (none/bad) to 10 cm (the most amount/good). |
| Food intake | After 360 minutes | Amount of provided meal consumed |
| Paracetamol (gastric emptying) | 180-360 minutes | Difference in plasma concentration between interventions |
| Other glucose-regulating hormones/gut hormones | 0-360 minutes | Difference in plasma concentration between interventions |
| Free fatty acids | 0-360 minutes | Difference in plasma concentration between interventions |
| Cholesterol | 0-360 minutes | Difference in plasma concentration between interventions |
| Bile acids | 0-360 minutes | Difference in plasma concentration between interventions |
| Cholecystokinin | 0-360 minutes | Difference in plasma concentration between interventions |
| Amino acids | 0-360 minutes | Difference in plasma concentration between interventions |
| Gallbladder emptying | 0-360 minutes | Gallbladder volume assessed by ultrasonography |
| Fatty acid amide hydrolase genotype | Baseline | Nucleobase sequence of the fatty acid amide hydrolase gene region of the DNA. |
| G-protein coupled receptor 119 genotype | Baseline | Nucleobase sequence of the G-protein coupled receptor 119 gene region of the DNA. |
| Triglyceride | 0-360 minutes | Difference in plasma concentration between interventions |
Outcome results
None listed