Status:
COMPLETED
Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
Lead Sponsor:
TNO
Collaborating Sponsors:
Chr Hansen
Conditions:
Overweight
Diabetes
Eligibility:
MALE
18-59 years
Phase:
NA
Brief Summary
In the present study it is hypothesized that a reduction of the inflammatory status may prevent the occurrence of disorders and diseases related to overweight. In this study the effects of nutritiona...
Detailed Description
From day -01 onwards until the end of the study, subjects will come to TNO every week. Each of the four study periods will be performed identically. In the first study period, on days -01, 07, 14, 21...
Eligibility Criteria
Inclusion
- Healthy as assessed by the Health and lifestyle questionnaire Physical examination. Results of the pre-study laboratory tests
- Males aged over 18 and \< 60 years at Day 01 of the study
- Body Mass Index (BMI): 26 - 35 (including) kg/m2
- C-reactive protein (CRP) 1-10 mg/L. Acute inflammation as reason for increased CRP to be excluded based on white blood cell counts
- Willing to use the study substances (yogurt and capsules) daily for 20 weeks
- Normal Dutch eating habits as assessed by questionnaire
- Voluntary participation and having given written informed consent
- Willing to comply with the study procedures, including no use of food supplements, probiotic containing products and NSAID
- Willing not to serve as blood donor during the study
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a chronic disease related to inflammation (such as arthritis) or a history of medical or surgical events that may significantly affect the study outcome, including diabetes (type 1 or 2) cardiovascular disease and hypothyroidemy
- High blood pressure (age \<55 y: DBP \> 100 or SBP \>160 mm Hg, age 55-59: DBP \> 90 or SBP \>140 mm Hg)
- Fasting blood glucose level \>6.9 mmol/L
- Fasting cholesterol \> 8 mmol/L
- Blood hemoglobin \< 8 mmol/L
- Use of medication that might interfere with parameters to be measured or with one of the treatments
- Frequent use of antibiotic medication (3 times or more in the past year)\*
- Frequent use of NSAID or paracetamol (frequency and/or urgency of need incompatible with participation - to be decided by medical investigator)
- Lactose intolerance
- Smoking
- Extreme physical exercise \> 6 hours/week
- Reported unexplained weight loss or gain of \> 4 kg in the month prior to the pre-study screening
- Alcohol consumption \> 28 units per week
- Reported slimming or medically prescribed diet
- Recent blood donation (\< 1 month prior to the start of the study)
- Personnel of TNO Quality of Life, their partner and their relatives in the first and second remove
- Not having a general practitioner
- Not willing to accept information transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00655798
Start Date
December 1 2006
End Date
June 1 2007
Last Update
April 10 2008
Active Locations (1)
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1
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3704 HE