Department of Nutrition, Exercise and Sports
Frederiksberg, 1958, Denmark
NCT Number: NCT03656367
The overall aim of this study is to investigate how dairy products with different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry.
The study will be conducted as a randomized acute cross-over meal study. Apparently healthy men will be recruited in the study. They will on 4 test days consume the 4 dairy products and blood will be drawn the following 8 hours.
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Notify Me18 year–40 year
Male
Interventional
Not applicable
Frederiksberg, 1958, Denmark
The overall aim of this study is to investigate how dairy products with similar nutrient content but different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR) and liquid chromatography mass spectrometry (LCMS)-based metabolomics.
The study will be conducted as a randomized acute cross-over meal study. On four different test days (with a minimum of 2 weeks washout period) four dairy products with similar nutrient composition but different structures or textures will be tested. During each meal test a single dairy product (+ bread and water) is served and postprandial blood samples are collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during the 8-hour period and an ad libitum meal is served in the end of the day.
25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The reference product is a commercial matured cheddar cheese
A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet
An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network
This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference
Time frame: 0-8 hour
The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.
Time frame: 0-8 hour
Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.
Time frame: 0-8 hour
Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).
Time frame: 0-8 hour
Detailed absorption kinetics will be evaluated by NMR-based metabolomics
Time frame: 0-8 hour
Subjective appetite sensation (e.g. hunger, satiety, thirst) will be evaluated by visual analogue scales (VAS). The VAS is a line (100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating of the subject's sensations. For example, Q: "How hungry do you feel now?", rating: "not at all" (=0 mm) and "extremely" (=100 mm)
Time frame: 8 hours after test meal
Acute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period
Time frame: 0-8 hour
Fasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.
Time frame: 0-8 hour
Detailed absorption kinetics will be evaluated by LCMS-based metabolomics
Anne Birgitte Raben
Other
Acronym: DAIRYMAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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