Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
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 nutritional compounds will be studied in overweight men with a low grade inflammatory status. We will investigate the effects of 3 different food treatments as compared to a placebo on markers of inflammation and on parameters of glucose and fat metabolism. The three different food treatments are a food mix and two yogurts each containing different probiotic strains. The food mix is composed of a mix of nutritional components, each reported to affect inflammation parameters and (or) anti-oxidant status but different in their -hypothesized-mode of action.
|Overweight Diabetes Cardiovascular Disease||Dietary Supplement: Placebo Dietary Supplement: Plain Yogurt + mix of anti-oxidants capsules Dietary Supplement: Yogurt containing Lactobacillus helveticus Dietary Supplement: Yogurt containing Bifidobacterium animalis ssp.|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men|
- inflammation parameters [ Time Frame: 5 weeks ]
- glucose and fat response [ Time Frame: 5 weeks ]
|Study Start Date:||December 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
Dietary Supplement: Placebo
plain yogurt and capsules containing cellulose
|Active Comparator: 2||
Dietary Supplement: Plain Yogurt + mix of anti-oxidants capsules
plain yogurt and capsules containing mix of anti-oxidants
|Active Comparator: 3||
Dietary Supplement: Yogurt containing Lactobacillus helveticus
Yogurt containing the probiotic Lactobacillus helveticus
|Active Comparator: 4||
Dietary Supplement: Yogurt containing Bifidobacterium animalis ssp.
Yogurt containing the probiotic Bifidobacterium animalis ssp.
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 and 28, subjects will come to TNO for collection of study substances for the coming week. On days 14, 21 and 28 they will come in a fasting state in the morning for blood sampling (fasting). Fasting blood samples will be taken by venapuncture.
After having received new study substances and the diary for the coming week, subjects can leave TNO.
On day 34, subjects will come to TNO at around 8:00 am and they will stay at TNO till about 11:00 for an oral glucose tolerance test. Fasting blood samples will be collected for determining treatment parameters. Subsequently subjects are provided the oral glucose load of 75 g glucose dissolved in 300 ml water. Blood samples will be taken at t= 90 and 120 min after the glucose load. After the last sample of the OGTT has been collected, subjects will be asked to void their bladder and afterwards receive a bottle for collection of 24 hour urine. The subjects will receive a free breakfast and can leave TNO.
The next day, on Day 35, subjects consume the breakfast as provided by TNO at home at around 8:00.They will come to TNO at around 11:00 am and they will stay at TNO till about 20:00. In addition, they will turn in the urine bottle after having voided their bladder at 24 after start of collection.
A canula will be inserted for collection of samples the rest of the day. At four hours after consumption subjects are provided a high fat meal. Blood samples will be taken at t = 30, 60, 120, 180, 240 and 360 min after the meal. Throughout the challenge sampling subjects are only allowed to drink water. After the last sample of the test has been taken subjects will receive a free dinner. After dinner an adipose tissue biopsy will be taken under local anesthesia.
The subjects will receive new study substances and diary for the coming week, starting on the next day.
In the next three study periods, the procedure will be identical.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655798
|TNO Quality of Life|
|Zeist, Utrecht, Netherlands, 3704 HE|
|Principal Investigator:||Gertruud Bakker, PhD||TNO Quality of Life, Zeist, The Netherlands|