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Antiinflammatory Effect of Dietary Protein Intake in Elderly People

Antiinflammatory Effect of Dietary Protein Intake in Elderly People

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02758795
Acronym
AEDP
Enrollment
16
Registered
2016-05-03
Start date
2016-02-29
Completion date
2017-04-08
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

protein, inflammation, anti-inflammatory agents

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTCONTROL

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'

DIETARY_SUPPLEMENTNUTRIENT

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'

Sponsors

Ireland: Department Agriculture Food and the Marine
CollaboratorUNKNOWN
University of Limerick
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinksMacrophages 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)All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinksMacrophages 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)All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinksMacrophages 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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026