Skip to content

STRONG

A study to evaluate the postprandial, short term effects of two baby nutrition products in healthy adult, male volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25466
Enrollment
30
Registered
2014-03-10
Start date
2014-03-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male volunteers.

Interventions

Duration of intervention: 9-12 days, consisting of 2 test days within 2 weeks A follow up call will take place 2 weeks after the last test day.

Sponsors

University Maastricht Department of Human Biology
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
Several plasma/serum parameters in response to ingestion of the active (and control) products are assessed.

Primary

MeasureTime frame
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.

Contacts

Public ContactMaaike Hofman

Nutricia Research BV Clinical Studies Platform Uppsalalaan 12

maaike.hofman@danone.com+31 (0)302095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)