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Completed

NCT Number: NCT02758795

Antiinflammatory Effect of Dietary Protein Intake in Elderly People

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, Co Limerick, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Dietary 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'

NUTRIENT

Dietary 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'

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Ireland: Department Agriculture Food and the Marine

Registry information

Acronym: AEDP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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