An interventional study of Cheddar cheese and Blended and homogenized cheddar cheese in Lipaemia, sponsored by Anne Birgitte Raben. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by Anne Birgitte Raben · Not applicable, Interventional, and Prevention
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.
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.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 25 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Anne Birgitte Raben is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Cross-over study (all subjects receive all interventions) * Cheddar cheese * Blended and homogenized cheddar cheese * An analog milk * An analog cheese
Dietary Supplement: Cheddar cheese · Dietary Supplement: Blended and homogenized cheddar cheese · Dietary Supplement: An analog milk · Dietary Supplement: An analog cheese
If any subjects (against our hypothesis) have indices of metabolic syndrome i.e. raised fasting glucose or TG concentration, secondary analyses will be conducted to assess results without these subjects. All subjects receive all interventions) * Cheddar cheese * Blended and homogenized cheddar cheese * An analog milk * An analog cheese
Dietary Supplement: Cheddar cheese · Dietary Supplement: Blended and homogenized cheddar cheese · Dietary Supplement: An analog milk · Dietary Supplement: An analog cheese
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
Triglyceride
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
Apolipoprotein B48
Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.
Time frame: 0-8 hour
Cholesterol (total, LDL and HDL cholesterol)
Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Free Fatty Acid (FFA)
Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Insulin
Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Glucose
Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.
Time frame: 0-8 hour
Apolipoproteins
Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.
Time frame: 0-8 hour
Paracetamol
Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).
Time frame: 0-8 hour
Metabolomics
Detailed absorption kinetics will be evaluated by NMR-based metabolomics
Time frame: 0-8 hour
Subjective appetite sensation
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: 0-8 hour
Acute energy intake
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: 8 hours after test meal
Appetite hormones
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 metabolomics
Detailed absorption kinetics will be evaluated by LCMS-based metabolomics
Time frame: 0-8 hour
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Anne Birgitte Raben