HealthyNCT01066091
Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
A study testing Mashed potatoes, Mashed potatoes + Oleic acid and mashed potatoes + Palmitic acid in people with Healthy and Obesity, run by Yves Boirie at 1 site in France.
Trial summary
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age. Read more about this study
- Who is it for?
- Ages 20 to 90 years, men onlyHealthy volunteers can take part
- What is being tested?
- Mashed potatoes, Mashed potatoes + Oleic acid and mashed potatoes + Palmitic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jan 2011
- 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 20 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject giving his written informed consent
- Male from 20 to 35 years old and more than 60
- Affiliated to the French National Health Insurance
- Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm.
- Complete blood count (CBC)-platelet, normal liver function and normal coagulation.
- Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative
- normal Thyroid Stimulating Hormone(TSH)
Who cannot join
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Glaucoma
- C-reactive protein > 10 mg/l
- people over 120 kg
- People with triglyceridemia > 3 g/L or with familial hypercholesterolemia
- Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test
Show all 18Show fewer
- Dietary habits judged by the dietitian as incompatible with the study aim
- Vegetarians
- Nutritional allergies or xylocaïn allergy
- People with eating disorders
- Heavy consumer of alcohol or cigarette
- Practising intensive physical exercise
- People with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days.
- Depression or psychiatric treatment
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file or refusal to sign the consent form
- Being in exclusion on the National Volunteers Data file
- Blood donation into the last two months preceding the study
Trial locations and contacts
1 site in 1 country.
About this study
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age.
The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.
Read the detailed description
32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men. They will come to the center four times after inclusion, with 2 to 4 weeks wash out each time. At the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength. At the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal. The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits. Before each of these three visits, a controlled diet will be established. At the last visit body composition and muscular strength will be evaluated.
- Being tested
- Mashed potatoes, Mashed potatoes + Oleic acid, mashed potatoes + Palmitic acid
- Keywords
- Inflammatory response, High-fat meal, cytokines, Body composition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mashed potatoesOther
Mashed potatoes: Potatoes + Skim milk powder
Mashed potatoes + Oleic acidOther
Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
mashed potatoes + Palmitic acidOther
Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
| Study group | Role | What they receive |
|---|---|---|
| mashed potatoes | Placebo comparator | Mashed potatoes is composed of potatoes and Skim milk powder. Receives: Other: Mashed potatoes |
| Mashed potatoes + Oleic Acid | Experimental | The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid Receives: Other: Mashed potatoes + Oleic acid |
| Mashed potatoes + Palmitic Acid | Experimental | The test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid. Receives: Other: mashed potatoes + Palmitic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
Measured: six times per day (kinetic: T0 to T480) on three interventional days
Secondary outcomes (4)
Muscular strength, Body composition
Measured: Once at the first and at the last visit
Total plasma lipids (total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglycerides (TG), non-esterified fatty acid, Plasma hormonal profile, Plasma inflammatory profile, Markers of Endothelial function, Plasma lipopolysaccharide concentration.
Measured: Six times per day (kinetic: T0 to T480), on three interventional days
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Measured: Twice per day (before the meal and 6 hours after), on three interventional days
Urinary metabolomic profile
Measured: Three times per days (T0,T240,T480), on three interventional days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yves Boirie
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, ITERG
- Responsible party
- Sponsor-investigator, Yves Boirie, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Yves Boirie, MD/PhD, Principal investigator, CRNHStephane Walrand, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066091
- Sponsor's protocol ID
- AU800
- Other IDs
- IDRCB 2009-A00322-55, 05/2009 SWALRAND
- Status last verified
- Jan 2011
- First submitted
- 9 Feb 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
- ClinicalTrials.gov ID
- NCT01066091
- Acronym / sponsor ID
- AU800
- Keywords
- Inflammatory response, High-fat meal, cytokines, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yves BoirieUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, ITERG
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Feb 2010 (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.
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age.
The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.
Detailed description
32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men. They will come to the center four times after inclusion, with 2 to 4 weeks wash out each time. At the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength. At the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal. The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits. Before each of these three visits, a controlled diet will be established. At the last visit body composition and muscular strength will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mashed potatoes | Placebo comparator | Other: Mashed potatoesMashed potatoes is composed of potatoes and Skim milk powder. |
| Mashed potatoes + Oleic Acid | Experimental | Other: Mashed potatoes + Oleic acidThe test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid |
| Mashed potatoes + Palmitic Acid | Experimental | Other: mashed potatoes + Palmitic acidThe test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject giving his written informed consent
- Male from 20 to 35 years old and more than 60
- Affiliated to the French National Health Insurance
- Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm.
- Complete blood count (CBC)-platelet, normal liver function and normal coagulation.
Key exclusion criteria (18 listed)
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Glaucoma
- C-reactive protein > 10 mg/l
- people over 120 kg
- People with triglyceridemia > 3 g/L or with familial hypercholesterolemia
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 |
|---|---|---|
| Mashed potatoesMashed potatoes: Potatoes + Skim milk powder | Other | mashed potatoes |
| Mashed potatoes + Oleic acidMashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid | Other | Mashed potatoes + Oleic Acid |
| mashed potatoes + Palmitic acidMashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid | Other | Mashed potatoes + Palmitic Acid |
Primary outcome
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
Time frame: six times per day (kinetic: T0 to T480) on three interventional days
4 secondary outcomes
Muscular strength, Body composition
Time frame: Once at the first and at the last visit
Total plasma lipids (total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglycerides (TG), non-esterified fatty acid, Plasma hormonal profile, Plasma inflammatory profile, Markers of Endothelial function, Plasma lipopolysaccharide concentration.
Time frame: Six times per day (kinetic: T0 to T480), on three interventional days
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
Time frame: Twice per day (before the meal and 6 hours after), on three interventional days
Urinary metabolomic profile
Time frame: Three times per days (T0,T240,T480), on three interventional days
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 25 Mar 2015.
- Related InfoLink provided by the sponsor.
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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.
Yves Boirie, MD/PhD principal investigator
CRNH
Stephane Walrand, PhD study director
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mashed potatoes, Mashed potatoes + Oleic acid and mashed potatoes + Palmitic acid in people with Healthy and Obesity, run by Yves Boirie at 1 site in France.
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 7 inclusion and 18 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 25 Mar 2015. 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 France. 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?
Inflammatory profile by interleukin-6 (IL6) concentration in plasma. (time frame: six times per day (kinetic: T0 to T480) on three interventional days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2015.