Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
Condition: Overweight; Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

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 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.
    

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 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.
    

Intervention name(s): Placebo; Plain Yogurt + mix of anti-oxidants capsules; Yogurt containing Lactobacillus helveticus; Yogurt containing Bifidobacterium animalis ssp.
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): plain yogurt and capsules containing cellulose; plain yogurt and capsules containing mix of anti-oxidants; Yogurt containing the probiotic Lactobacillus helveticus; Yogurt containing the probiotic Bifidobacterium animalis ssp.
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention