- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758795
Antiinflammatory Effect of Dietary Protein Intake in Elderly People (AEDP)
Study Overview
Status
Conditions
Intervention / Treatment
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(ii) a 10ml blood sample will be withdrawn and aliquots generated for subsequent analysis; (iii) Following a 15 min rest period subjects will be given in randomised order either control (CONTROL) - a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 further blood samples will be withdrawn at 0, 15, 30, 45, 60 75, 90, 120 and 180 minutes post feeding.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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Co Limerick
-
Limerick, Co Limerick, Ireland
- University of Limerick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: CONTROL
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
|
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'
|
Active Comparator: NUTRIENT
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
|
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'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
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
|
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)
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
|
All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Jakeman, PhD, University of Limerick
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIRM2016
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