Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

NCT00655798 | Completed

• 1 other identifier: P6957
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Diabetes; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• inflammation parameters

  5 weeks

Secondary Outcomes (1)

• glucose and fat response

  5 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Dietary Supplement: Placebo

2

ACTIVE COMPARATOR

Dietary Supplement: Plain Yogurt + mix of anti-oxidants capsules

3

ACTIVE COMPARATOR

Dietary Supplement: Yogurt containing Lactobacillus helveticus

4

ACTIVE COMPARATOR

Dietary Supplement: Yogurt containing Bifidobacterium animalis ssp.

Interventions

Placebo DIETARY_SUPPLEMENT

plain yogurt and capsules containing cellulose

1

Plain Yogurt + mix of anti-oxidants capsules DIETARY_SUPPLEMENT

plain yogurt and capsules containing mix of anti-oxidants

2

Yogurt containing Lactobacillus helveticus DIETARY_SUPPLEMENT

Yogurt containing the probiotic Lactobacillus helveticus

3

Yogurt containing Bifidobacterium animalis ssp. DIETARY_SUPPLEMENT

Yogurt containing the probiotic Bifidobacterium animalis ssp.

4

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TNO: lead
• Novonesis: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704 HE, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 20181810 DERIVED

MeSH Terms

Conditions

Overweight; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gertruud Bakker, PhD

  TNO Quality of Life, Zeist, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: December 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 10, 2008

Record last verified: 2008-04

Locations

NL (1)