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Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

Primary Purpose

Overweight, Diabetes, Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Placebo

Plain Yogurt + mix of anti-oxidants capsules

Yogurt containing Lactobacillus helveticus

Yogurt containing Bifidobacterium animalis ssp.

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - 59 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

TNO Quality of Life

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

inflammation parameters

Secondary Outcome Measures

glucose and fat response

Full Information

NCT ID

NCT00655798

First Posted

April 4, 2008

Last Updated

April 4, 2008

Sponsor

TNO

Collaborators

Chr Hansen

1. Study Identification

Unique Protocol Identification Number

NCT00655798

Brief Title

Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

Official Title

Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

TNO

Collaborators

Chr Hansen

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Diabetes, Cardiovascular Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

plain yogurt and capsules containing cellulose

Intervention Type

Dietary Supplement

Intervention Name(s)

Plain Yogurt + mix of anti-oxidants capsules

Intervention Description

plain yogurt and capsules containing mix of anti-oxidants

Intervention Type

Dietary Supplement

Intervention Name(s)

Yogurt containing Lactobacillus helveticus

Intervention Description

Yogurt containing the probiotic Lactobacillus helveticus

Intervention Type

Dietary Supplement

Intervention Name(s)

Yogurt containing Bifidobacterium animalis ssp.

Intervention Description

Yogurt containing the probiotic Bifidobacterium animalis ssp.

Primary Outcome Measure Information:

Title

inflammation parameters

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

glucose and fat response

Time Frame

5 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gertruud Bakker, PhD

Organizational Affiliation

TNO Quality of Life, Zeist, The Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

TNO Quality of Life

City

Zeist

State/Province

Utrecht

ZIP/Postal Code

3704 HE

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

20181810

Citation

Bakker GC, van Erk MJ, Pellis L, Wopereis S, Rubingh CM, Cnubben NH, Kooistra T, van Ommen B, Hendriks HF. An antiinflammatory dietary mix modulates inflammation and oxidative and metabolic stress in overweight men: a nutrigenomics approach. Am J Clin Nutr. 2010 Apr;91(4):1044-59. doi: 10.3945/ajcn.2009.28822. Epub 2010 Feb 24.

Results Reference

derived

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Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

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