Back to resultsEffects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST)
Primary Purpose
Hypertriglyceridemia
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DHA-NAT
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypertriglyceridemia focused on measuring N-acyl taurine
Eligibility Criteria
Inclusion Criteria: Male Healthy Age between 18 and 30 years Body mass index between 18.5-25 kg/m2 Informed consent Moderate level of physical activity assessed with IPAQ (short version) Exclusion Criteria: Use of fish-oil/omega-3 FA supplements within the last 3 months Regular tobacco smoking or use of other nicotine-containing products Allergy or intolerance to ingredients included in the standardised meals Weekly intake of fish >350 g (23) First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) >48 mmol/mol, familial hypercholesterolemia/hyperlipidemia Anaemia (haemoglobin below 8.3 mmol/L) Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times upper normal values (Normal values: ALAT < 70 U/L, ASAT <45 U/L) Nephropathy (serum creatinine >105 μmol/L) and/or albuminuria (>30 mg/g albumin in urine)) History of hepatobiliary or gastrointestinal disorder(s) Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
Sites / Locations
- Center for Clinical Metabolic Research, Herlev-Gentofte HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DHA-NAT
Placebo
Arm Description
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
Outcomes
Primary Outcome Measures
Plasma triglyceride
Change in incremental area-under-curve plasma triglyceride
Secondary Outcome Measures
Plasma GLP-1
Plasma GLP-1 profile
Plasma N-acyl taurine species
Profile of plasma n-acyl taurine species
Plasma ApoB48
Plasma ApoB48 profile
Satiety, hunger and appetite
Development during study day recorded by visual analogue scale (VAS), 0-10 cm where 0 = not in agreement with statement and 10 = in agreement with statement.
Food intake (g)
Grams consumed of a standard ad libitum meal
Food intake (kcal)
kcal consumed of a standard ad libitum meal
Plasma triglyceride (TG) distribution
total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG
Plasma free fatty acid species
Total fatty acids profile
Plasma cholesterol
Total cholesterol, HDL, LDL, VLDL, remnant cholesterol
Plasma level of glucose regulating hormones
Insulin, glucagon and gastric inhibitory polypeptide
Plasma amino acids
Total amino acids profile
Plasma glucose
Plasma glucose profile
Plasma bile acid species
Plasma bile acid profile
Gall bladder emptying: Cholecystokinin
Cholecystokinin profile
Gall bladder emptying: Ultrasonography
Difference in volume from most to least full
Gastric emptying: Paracetamol
Plasma acetaminphen profile
Stool quality
Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid)
Full Information
NCT ID
NCT05953064
First Posted
June 20, 2023
Last Updated
July 11, 2023
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT05953064
Brief Title
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
Acronym
FEAST
Official Title
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of DHA-NAT (C22:6 N-acyl taurine, an endogenous metabolite derived from the omega-3 fatty acid, docosahexaenoic acid) on postprandial plasma triglyceride levels following a high-fat meal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
N-acyl taurine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DHA-NAT
Arm Type
Experimental
Arm Description
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
Intervention Type
Other
Intervention Name(s)
DHA-NAT
Other Intervention Name(s)
C22:6 N-acyl taurine
Intervention Description
Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).
Primary Outcome Measure Information:
Title
Plasma triglyceride
Description
Change in incremental area-under-curve plasma triglyceride
Time Frame
0-240 minutes
Secondary Outcome Measure Information:
Title
Plasma GLP-1
Description
Plasma GLP-1 profile
Time Frame
0-240 minutes
Title
Plasma N-acyl taurine species
Description
Profile of plasma n-acyl taurine species
Time Frame
0-240 minutes
Title
Plasma ApoB48
Description
Plasma ApoB48 profile
Time Frame
0-240 minutes
Title
Satiety, hunger and appetite
Description
Development during study day recorded by visual analogue scale (VAS), 0-10 cm where 0 = not in agreement with statement and 10 = in agreement with statement.
Time Frame
0-240 minutes
Title
Food intake (g)
Description
Grams consumed of a standard ad libitum meal
Time Frame
t=240 minutes
Title
Food intake (kcal)
Description
kcal consumed of a standard ad libitum meal
Time Frame
t=240 minutes
Title
Plasma triglyceride (TG) distribution
Description
total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG
Time Frame
0-240 minutes
Title
Plasma free fatty acid species
Description
Total fatty acids profile
Time Frame
0-240 minutes
Title
Plasma cholesterol
Description
Total cholesterol, HDL, LDL, VLDL, remnant cholesterol
Time Frame
0-240 minutes
Title
Plasma level of glucose regulating hormones
Description
Insulin, glucagon and gastric inhibitory polypeptide
Time Frame
0-240 minutes
Title
Plasma amino acids
Description
Total amino acids profile
Time Frame
0-240 minutes
Title
Plasma glucose
Description
Plasma glucose profile
Time Frame
0-240 minutes
Title
Plasma bile acid species
Description
Plasma bile acid profile
Time Frame
0-240 minutes
Title
Gall bladder emptying: Cholecystokinin
Description
Cholecystokinin profile
Time Frame
0-240 minutes
Title
Gall bladder emptying: Ultrasonography
Description
Difference in volume from most to least full
Time Frame
0-240 minutes
Title
Gastric emptying: Paracetamol
Description
Plasma acetaminphen profile
Time Frame
0-240 minutes
Title
Stool quality
Description
Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid)
Time Frame
Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Healthy
Age between 18 and 30 years
Body mass index between 18.5-25 kg/m2
Informed consent
Moderate level of physical activity assessed with IPAQ (short version)
Exclusion Criteria:
Use of fish-oil/omega-3 FA supplements within the last 3 months
Regular tobacco smoking or use of other nicotine-containing products
Allergy or intolerance to ingredients included in the standardised meals
Weekly intake of fish >350 g (23)
First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) >48 mmol/mol, familial hypercholesterolemia/hyperlipidemia
Anaemia (haemoglobin below 8.3 mmol/L)
Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times upper normal values (Normal values: ALAT < 70 U/L, ASAT <45 U/L)
Nephropathy (serum creatinine >105 μmol/L) and/or albuminuria (>30 mg/g albumin in urine))
History of hepatobiliary or gastrointestinal disorder(s)
Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katja T Michler, M.Sc
Phone
+4530516729
Email
katja.michler@sund.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Casper K Nielsen, PhD
Phone
+4560117434
Email
casper.kjaersgaard.nielsen@regionh.dk
Facility Information:
Facility Name
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja T Michler, MSc
Phone
+4530516729
Email
katja.michler@sund.ku.dk
First Name & Middle Initial & Last Name & Degree
Filip Knop, MD, prof.
Phone
38674266
Email
filip.krag.knop.01@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
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