Antiinflammatory Effect of Dietary Protein Intake in Elderly People

NCT02758795 | Completed DMC

• 1 other identifier: FIRM2016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

protein; inflammation; anti-inflammatory agents

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks

Study Arms (2)

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

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

Dietary Supplement: NUTRIENT

Interventions

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'

CONTROL

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'

NUTRIENT

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead
• Ireland: Department Agriculture Food and the Marine: collaborator

Study Sites (1)

University of Limerick

Limerick, Co Limerick, Ireland

Location

MeSH Terms

Conditions

Inflammation

Interventions

Nutrients

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Philip Jakeman, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: May 3, 2016
• Study Start: February 1, 2016
• Primary Completion: April 8, 2017
• Study Completion: April 8, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

IE (1)