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A randomized, cross-over, open label trial on human plasma metabolome and cytokine profiling of no and high dairy consumption - a pilot study

A randomized, cross-over, open label trial on human plasma metabolome and cytokine profiling of no and high dairy consumption - a pilot study - Plasma metabolome and cytokine profiling of no and high dairy consumption

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37567
Enrollment
10
Registered
2012-05-07
Start date
2012-05-24
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

niet van toepassing N/A

Interventions

None listed

Sponsors

Campina
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subject needs to be in a healthy condition as assessed by health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests; - Men, aged 30 to 40 years, inclusive, on study day 1; - Body Mass Index (BMI) in the range of 23 to 28 kg/m2; - Waist circumference

Exclusion criteria

Exclusion criteria: - Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; - Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; - A reported food allergy or sensitivity (wheat, milk, eggs, nuts, etc); - Reported unexplained weight loss or weight gain of > 2 kg in the month prior to screening; - Reported slimming or medically prescribed diet;

Design outcomes

Primary

MeasureTime frame
At the end of each intervention period, t=0 (fasting) and 4 timepoints postprandially, parameters for metabolomics (basal metabolism (energy metabolism, urea cycle, glucose metabolism, ketonbodies, lipid metabolism, aminoacids etc), oxidative stress) and cytokines (IL1-beta, IL-6, IL-8, IL-10, IL-12, TNF-alpha, IFN-gamma) are measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)