Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

Diabetes Clinical Trial

Official title:

Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655798
• Other study ID #: P6957
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: April 4, 2008
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2008
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Healthy as assessed by the Health and lifestyle questionnaire Physical examination. Results of the pre-study laboratory tests

2. Males aged over 18 and < 60 years at Day 01 of the study

3. Body Mass Index (BMI): 26 - 35 (including) kg/m2

4. C-reactive protein (CRP) 1-10 mg/L. Acute inflammation as reason for increased CRP to be excluded based on white blood cell counts

5. Willing to use the study substances (yogurt and capsules) daily for 20 weeks

6. Normal Dutch eating habits as assessed by questionnaire

7. Voluntary participation and having given written informed consent

8. Willing to comply with the study procedures, including no use of food supplements, probiotic containing products and NSAID

9. Willing not to serve as blood donor during the study

10. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data

11. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study

2. 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

3. 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

4. High blood pressure (age <55 y: DBP > 100 or SBP >160 mm Hg, age 55-59: DBP > 90 or SBP >140 mm Hg)

5. Fasting blood glucose level >6.9 mmol/L

6. Fasting cholesterol > 8 mmol/L

7. Blood hemoglobin < 8 mmol/L

8. Use of medication that might interfere with parameters to be measured or with one of the treatments

9. Frequent use of antibiotic medication (3 times or more in the past year)*

10. Frequent use of NSAID or paracetamol (frequency and/or urgency of need incompatible with participation - to be decided by medical investigator)

11. Lactose intolerance

12. Smoking

13. Extreme physical exercise > 6 hours/week

14. Reported unexplained weight loss or gain of > 4 kg in the month prior to the pre-study screening

15. Alcohol consumption > 28 units per week

16. Reported slimming or medically prescribed diet

17. Recent blood donation (< 1 month prior to the start of the study)

18. Personnel of TNO Quality of Life, their partner and their relatives in the first and second remove

19. Not having a general practitioner

20. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Overweight

Intervention

Dietary Supplement:
• Placebo
plain yogurt and capsules containing cellulose
• Plain Yogurt + mix of anti-oxidants capsules
plain yogurt and capsules containing mix of anti-oxidants
• Yogurt containing Lactobacillus helveticus
Yogurt containing the probiotic Lactobacillus helveticus
• Yogurt containing Bifidobacterium animalis ssp.
Yogurt containing the probiotic Bifidobacterium animalis ssp.

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life	Zeist	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
TNO	Chr Hansen A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation parameters		5 weeks	No
Secondary	glucose and fat response		5 weeks	No