InflammationAEDPNCT02758795
Antiinflammatory Effect of Dietary Protein Intake in Elderly People
A study testing NUTRIENT in people with Inflammation, run by University of Limerick at 1 site in Ireland.
Trial summary
The aim is to evaluate the effect of ingestion of a modified bovine milk protein on circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy ageing, i.e. delaying the deterioration in health status in older adults. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- NUTRIENT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2016to 8 Apr 2017
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women
- Aged 50 to 70y
- Conducted by a medical doctor and based on Grieg et al. 1994 to be 'healthy' (i.e. 'disease-free') free-living and fully mobile
Who cannot join
- Age <50 or > 70y.
- Contraindication identified by medical doctor based on Grieg et al. 1994 definition of 'healthy' (i.e. 'disease-free') free-living and fully mobile older subjects
- Lactose intolerant or intolerance to dairy-based foods.
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to evaluate the effect of ingestion of a modified bovine milk protein on circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue mass, termed sarcopenia is a consequence of aging per se, modified by nutrition and lifestyle behaviour. Advancing the prospect of 'successful aging' a 6-month period of protein-based nutritional support has shown preservation/accrual of lean tissue. Chronic low-grade inflammation is common in ageing and is a compounding factor leading to 'anabolic blunting', i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue mass in response to protein feeding. Using a simulated human gastrointestinal digestion model we have recently shown proteins to have an anti-inflammatory bioactivity in vitro. This study investigates whether the anti-inflammatory response is retained, post-digestion in vivo.
Read the detailed description
Participants to be recruited, are aged 50 to 70y from the Healthy Aging Study (EHSREC10_45) who will attend on 4 test days (occasions)
Study Design: Single blind, randomised, repeated measures design with 2 independent factor (time x treatment)
Procedures:
Occasion 1 Subjects will undertake a preliminary assessment as per EHSREC 10_45 as follows; i. medical history and examination by a qualified medical doctor (~45 min); ii. provide a blood and urine sample to be evaluated (following analysis) by a qualified medical doctor;
Occasion 2 Subjects will then undertake, as per EHSREC 2013 01_12, an assessment of body composition, dietary intake and habitual physical activity as follows; iii. habitual food intake evaluated by a qualified dietitian (~45 min); iv. body composition (~45 min) v. habitual physical activity level (PAL) quantified using the European Physical Activity Questionnaire (EPAQ-2; ~ 15 min).
Occasion 3/4
Subjects will then undertake two controlled feeding trials, each trial separated by approximately 7 days as follows:
Subjects will report to the Metabolic Laboratory (PG-052b), Physical Education and Sports Sciences (PESS) Building following an overnight fast.
(i) A cannula will be inserted into a peripheral arm vein by a qualified clinician or phlebotomist;
(ii) a 10ml blood sample will be withdrawn and aliquots generated for subsequent analysis; (iii) Following a 15 min rest period subjects will be given in randomised order either control (CONTROL) - a placebo nutrient drink (per kg of body mass: 0.33g protein with no anti-inflammatory bioactivity; energy ~ 160 kcal in 500ml water) or nutrient (NUTRIENT) - a nutrient drink (per kg of body mass: 0.33g protein with confirmed anti-inflammatory bioactivity; energy ~ 160 kcal in 500ml water) to be consumed within a 10 minute period.
CONTROL and NUTRIENT will be reversed for the 2nd trial in randomised order.
(iv) Whilst remaining sitting at rest (reading, undertaking computer work etc.) further blood samples will be withdrawn at 0, 15, 30, 45, 60 75, 90, 120 and 180 minutes post feeding.
Total blood draw = 100ml per trial.
Data Analysis: (i) Shapiro-Wilk test of normality, then (ii) repeated measures analysis either by ANOVA(R) if normal or Friedman Test if non-normally distributed.
- Conditions
- Inflammation
- Being tested
- CONTROL, NUTRIENT
- Keywords
- protein, inflammation, anti-inflammatory agents
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROLDietary supplement
Following an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake'
NUTRIENTDietary supplement
Following an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake'
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Placebo comparator | A placebo nutrient drink with no anti-inflammatory bioactivity (measure by cell bioassay in vitro) Dose provided per kg of body mass: 0.33g protein mixed in 500ml of water as a protein 'shake' Energy ~ 160 kcal Receives: Dietary Supplement: CONTROL |
| NUTRIENT | Active comparator | A nutrient drink with confirmed anti-inflammatory bioactivity (measured by cell bioassay in vitro) Dose provided per kg of body mass: 0.33g protein mixed in 500ml of water as a protein 'shake' Energy ~ 160 kcal Receives: Dietary Supplement: NUTRIENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Macrophages seeded at a density of 0.2 x 10^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
Measured: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Tumour necrosis factor alpha (TNF-alpha) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Macrophages seeded at a density of 0.2 x 10^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
Measured: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Interleukin-1 beta (IL1_beta) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Macrophages seeded at a density of 2 x 10^5 cells/ml, stimulated with LPS (0.2ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
Measured: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startFeb 2016
- Primary completion8 Apr 2017
- Study completion8 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Ireland: Department Agriculture Food and the Marine
- Responsible party
- Principal investigator, Phil Jakeman, University of Limerick
- Investigators
- Philip Jakeman, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758795
- Sponsor's protocol ID
- FIRM2016
- Acronym
- AEDP
- Status last verified
- Jul 2017
- First submitted
- 12 Feb 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiinflammatory Effect of Dietary Protein Intake in Elderly People
- ClinicalTrials.gov ID
- NCT02758795
- Acronym / sponsor ID
- AEDP / FIRM2016
- Conditions
- Inflammation
- Keywords
- protein, inflammation, anti-inflammatory agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Ireland: Department Agriculture Food and the Marine
- Study start
- Feb 2016
- Primary completion
- 8 Apr 2017 (actual)
- Study completion
- 8 Apr 2017 (actual)
- First posted
- 3 May 2016 (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 aim is to evaluate the effect of ingestion of a modified bovine milk protein on circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue mass, termed sarcopenia is a consequence of aging per se, modified by nutrition and lifestyle behaviour. Advancing the prospect of 'successful aging' a 6-month period of protein-based nutritional support has shown preservation/accrual of lean tissue. Chronic low-grade inflammation is common in ageing and is a compounding factor leading to 'anabolic blunting', i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue mass in response to protein feeding. Using a simulated human gastrointestinal digestion model we have recently shown proteins to have an anti-inflammatory bioactivity in vitro. This study investigates whether the anti-inflammatory response is retained, post-digestion in vivo.
Detailed description
Participants to be recruited, are aged 50 to 70y from the Healthy Aging Study (EHSREC10_45) who will attend on 4 test days (occasions)
Study Design: Single blind, randomised, repeated measures design with 2 independent factor (time x treatment)
Procedures:
Occasion 1 Subjects will undertake a preliminary assessment as per EHSREC 10_45 as follows; i. medical history and examination by a qualified medical doctor (~45 min); ii. provide a blood and urine sample to be evaluated (following analysis) by a qualified medical doctor;
Occasion 2 Subjects will then undertake, as per EHSREC 2013 01_12, an assessment of body composition, dietary intake and habitual physical activity as follows; iii. habitual food intake evaluated by a qualified dietitian (~45 min); iv. body composition (~45 min) v. habitual physical activity level (PAL) quantified using the European Physical Activity Questionnaire (EPAQ-2; ~ 15 min).
Occasion 3/4
Subjects will then undertake two controlled feeding trials, each trial separated by approximately 7 days as follows:
Subjects will report to the Metabolic Laboratory (PG-052b), Physical Education and Sports Sciences (PESS) Building following an overnight fast.
(i) A cannula will be inserted into a peripheral arm vein by a qualified clinician or phlebotomist;
(ii) a 10ml blood sample will be withdrawn and aliquots generated for subsequent analysis; (iii) Following a 15 min rest period subjects will be given in randomised order either control (CONTROL) - a placebo nutrient drink (per kg of body mass: 0.33g protein with no anti-inflammatory bioactivity; energy ~ 160 kcal in 500ml water) or nutrient (NUTRIENT) - a nutrient drink (per kg of body mass: 0.33g protein with confirmed anti-inflammatory bioactivity; energy ~ 160 kcal in 500ml water) to be consumed within a 10 minute period.
CONTROL and NUTRIENT will be reversed for the 2nd trial in randomised order.
(iv) Whilst remaining sitting at rest (reading, undertaking computer work etc.) further blood samples will be withdrawn at 0, 15, 30, 45, 60 75, 90, 120 and 180 minutes post feeding.
Total blood draw = 100ml per trial.
Data Analysis: (i) Shapiro-Wilk test of normality, then (ii) repeated measures analysis either by ANOVA(R) if normal or Friedman Test if non-normally distributed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Placebo comparator | Dietary Supplement: CONTROLA placebo nutrient drink with no anti-inflammatory bioactivity (measure by cell bioassay in vitro) Dose provided per kg of body mass: 0.33g protein mixed in 500ml of water as a protein 'shake' Energy ~ 160 kcal |
| NUTRIENT | Active comparator | Dietary Supplement: NUTRIENTA nutrient drink with confirmed anti-inflammatory bioactivity (measured by cell bioassay in vitro) Dose provided per kg of body mass: 0.33g protein mixed in 500ml of water as a protein 'shake' Energy ~ 160 kcal |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women
- Aged 50 to 70y
- Conducted by a medical doctor and based on Grieg et al. 1994 to be 'healthy' (i.e. 'disease-free') free-living and fully mobile
Key exclusion criteria (3 listed)
- Age <50 or > 70y.
- Contraindication identified by medical doctor based on Grieg et al. 1994 definition of 'healthy' (i.e. 'disease-free') free-living and fully mobile older subjects
- Lactose intolerant or intolerance to dairy-based foods.
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 |
|---|---|---|
| CONTROLFollowing an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake' | Dietary supplement | CONTROL |
| NUTRIENTFollowing an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake' | Dietary supplement | NUTRIENT |
Primary outcome
Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Time frame: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Macrophages seeded at a density of 0.2 x 10^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
Tumour necrosis factor alpha (TNF-alpha) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Time frame: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Macrophages seeded at a density of 0.2 x 10^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
Interleukin-1 beta (IL1_beta) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)
Time frame: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
Macrophages seeded at a density of 2 x 10^5 cells/ml, stimulated with LPS (0.2ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum
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 1 Aug 2017.
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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.
Philip Jakeman, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRIENT in people with Inflammation, run by University of Limerick at 1 site in Ireland.
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 3 inclusion and 3 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 1 Aug 2017. 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 Ireland. 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?
Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS) (time frame: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks). The study lists 3 primary outcomes in all. 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 1 Aug 2017.