MedPath

STRONG

Completed
Conditions
Healthy male volunteers.
Registration Number
NL-OMON25466
Lead Sponsor
niversity MaastrichtDepartment of Human Biology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

Healthy, adult, male, Caucasian, Dutch-speaking subjects
- Non-smokers
- Lactose- and milk-tolerant
- Age 18-25 yr
- Body Mass Index (BMI) of 20-25 kg/m2
- Girth width <100 cm
- Stable body weight (weight gain or loss < 2 kg in the past three months)
- Written informed consent
- Willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study, and 4 weeks after the study (i.e. after the follow-up phone call)

Exclusion Criteria

-Top sports men or athletes with a daily strenuous training program (>2 hr/day)
-Known diseases or malfunctions e.g. fat malabsorption, gastrointestinal malformations, haemophilia, hepatitis B, human immunodeficiency virus (HIV), high blood-pressure, hyperlipidaemia or diabetes
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation, severe flu): to be determined on judgement of the investigator.
- Medication use (except for paracetamol) or a medically prescribed diet during the study
- Any current participation, or participation within 8 weeks before study start, in any other study involving investigational or marketed products
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements and instructions
- More than 21 alcoholic consumptions per week

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome parameter in this study comprises the postprandial time course of plasma TG levels after ingestion of the active product vs. the control. Apart from plasma TG levels per se, either absolute (mM) or delta values, also the derivative AUC or iAUC are considered as primary outcome parameter.
Secondary Outcome Measures
NameTimeMethod
Several plasma/serum parameters in response to ingestion of the active (and control) products are assessed.
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