OverweightNCT00655798
Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
A study testing Plain Yogurt + mix of anti-oxidants capsules, Yogurt containing Lactobacillus helveticus and Yogurt containing Bifidobacterium animalis ssp. in people with Overweight and Diabetes, run by TNO at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Diabetes, Cardiovascular Disease
- What is being tested?
- Plain Yogurt + mix of anti-oxidants capsules, Yogurt containing Lactobacillus helveticus and Yogurt containing Bifidobacterium animalis ssp.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overweight, Diabetes, Cardiovascular Disease
- Being tested
- Placebo, Plain Yogurt + mix of anti-oxidants capsules, Yogurt containing Lactobacillus helveticus, Yogurt containing Bifidobacterium animalis ssp.
- Medical subject headings
- Overweight, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
plain yogurt and capsules containing cellulose
Plain Yogurt + mix of anti-oxidants capsulesDietary supplement
plain yogurt and capsules containing mix of anti-oxidants
Yogurt containing Lactobacillus helveticusDietary supplement
Yogurt containing the probiotic Lactobacillus helveticus
Yogurt containing Bifidobacterium animalis ssp.Dietary supplement
Yogurt containing the probiotic Bifidobacterium animalis ssp.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | Not described Receives: Dietary Supplement: Plain Yogurt + mix of anti-oxidants capsules |
| 3 | Active comparator | Not described Receives: Dietary Supplement: Yogurt containing Lactobacillus helveticus |
| 4 | Active comparator | Not described Receives: Dietary Supplement: Yogurt containing Bifidobacterium animalis ssp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation parameters
Measured: 5 weeks
Secondary outcomes (1)
glucose and fat response
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startDec 2006
- Primary completionMay 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Novonesis
- Investigators
- Gertruud Bakker, PhD, Principal investigator, TNO Quality of Life, Zeist, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655798
- Sponsor's protocol ID
- P6957
- Status last verified
- Apr 2008
- First submitted
- 4 Apr 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
Publications
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.
PubMed 20181810
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
- ClinicalTrials.gov ID
- NCT00655798
- Acronym / sponsor ID
- P6957
- Conditions
- Overweight, Diabetes, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Novonesis
- Study start
- Dec 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplain yogurt and capsules containing cellulose | Dietary supplement | 1 |
| Plain Yogurt + mix of anti-oxidants capsulesplain yogurt and capsules containing mix of anti-oxidants | Dietary supplement | 2 |
| Yogurt containing Lactobacillus helveticusYogurt containing the probiotic Lactobacillus helveticus | Dietary supplement | 3 |
| Yogurt containing Bifidobacterium animalis ssp.Yogurt containing the probiotic Bifidobacterium animalis ssp. | Dietary supplement | 4 |
Primary outcome
inflammation parameters
Time frame: 5 weeks
1 secondary outcome
glucose and fat response
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
- Derived from this study: PubMed 20181810Bakker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gertruud Bakker, PhD principal investigator
TNO Quality of Life, Zeist, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain Yogurt + mix of anti-oxidants capsules, Yogurt containing Lactobacillus helveticus and Yogurt containing Bifidobacterium animalis ssp. in people with Overweight and Diabetes, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation parameters (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.