CompletedNot Applicable

Inflammaging and Muscle Protein Metabolism

Greece44 participantsStarted 2017-09-01

Plain-language summary

The development of a low-grade, chronic, systemic inflammation observed in the elderly (inflammaing) has been associated with increased risk for skeletal muscle wasting, strength loss and functional impairments. According to studies performed in animals and cell cultures increased concentrations of pro-inflammatory cytokines such as IL-6 and TNF-α as well as increased levels of hs-CRP lead to elevated protein degradation through proteasome activation and reduced muscle protein synthesis (MPS) via downregulation of the Akt-mTOR signaling pathway. However, evidence regarding the effects of inflammaging on skeletal muscle mass in humans is lacking. Thus, the present study will compare proteasome activation and the protein synthetic response in the fasted and postprandial period between older adults with increased systemic inflammation and their healthy control counterparts.

Who can participate

Age range

63 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-smokers. * BMI ≥18.5 \& BMI ≤ 35 kg/m2. * Moderately active but with no regular participation in heavy resistance exercise within the last 6 months. * Absence of chronic disease (i.e. cancer, metabolic, cardiac, or neurological diseases). * Free and independently living. Exclusion Criteria: * Organ failure (unstable, renal, respiratory, liver). * Chronic use of corticosteroid medication. * Recent use of antibiotics. * Presence of frailty. * Body weight variation over the past 6mo \> 10% or weight loss of more than 3kg in the last 3 months. * Use of anti-inflammatory or lipid-lowering medication (i.e., statins). * Use of medication interacting with muscle metabolism.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Systemic inflammation

Timeframe: At baseline.

Change in muscle protein synthesis (MPS)

Timeframe: At baseline and 180 min following protein ingestion.

Change in intracellular signaling proteins in muscle

Timeframe: At baseline and 180 min following protein ingestion.

Change in proteasome activities in muscle

Timeframe: At baseline and 180 min following protein ingestion.

Change in protein expression level of proteasome subunits

Timeframe: At baseline and 180 min following protein ingestion.

Trial details

NCT IDNCT03308747

SponsorUniversity of Thessaly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-15

View on ClinicalTrials.gov More Inflammaging trials

Plain-language summary

Who can participate

Age range

63 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Systemic inflammation

Timeframe: At baseline.

Change in muscle protein synthesis (MPS)

Timeframe: At baseline and 180 min following protein ingestion.

Change in intracellular signaling proteins in muscle

Timeframe: At baseline and 180 min following protein ingestion.

Change in proteasome activities in muscle

Timeframe: At baseline and 180 min following protein ingestion.

Change in protein expression level of proteasome subunits

Timeframe: At baseline and 180 min following protein ingestion.