Aging, Healthy, Inflammation
Conditions
Keywords
Eggshell membrane, Healthy volunteers, Old volunteers
Brief summary
The aim of this project is to evaluate daily intake of eggshell membrane taken as supplement (capsule), will reduce markers of inflammation in older people.
Interventions
OTHEREggshell membrane (ESM)
The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.
OTHERPlacebo
The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks
Sponsors
Nofima
Norwegian University of Life Sciences
Nortuna
Norilia
Orkla
Danægg
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
One of the employees will distribute the capsules and know which of the group is placebo and intervention. Everyone else involved in the project will be blinded for this knowledge.
Intervention model description
This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
The study will include home-dwelling men and women ≥ 70 years. All subjects have to be in a good enough condition to meet up at the Department of Nutrition, University of Oslo at two occasions during the study period.
Exclusion criteria
* CRP \>10 mg/L * Egg allergy * Use of medication affecting inflammation * Unstable use of medication or supplements last 3 months * Unwilling to keep the physical activity level, habitual dietary intake, tobacco use and weight stable during the study period * Severe illness last 3 months * Unwilling to perform physical tests * Eligibility * Diabetes type I or II, HbA1c ≥ 6.5 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma levels of inflammatory markers | Measured at baseline and after 4 weeks (end of study) | concentration of C-reactive protein (CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength | Measured at baseline and after 4 weeks | Measured by grip strength |
| Changes in markers related to lipid metabolism | Measured at baseline and after 4 weeks | Blood concentrations of e.g. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses |
| Peripheral blood mononuclear cell (PBMC) gene expression | Measured at baseline and after 4 weeks | mRNA levels of of genes involved in lipid metabolism and inflammation |
| Change in microbiota composition (optional) | Measured at baseline and after 4 weeks | Consenctration of faecal short-chain fatty acids |
| Changes in body composition - measured by Bioimpedance (BIA) | Measured at baseline and after 4 weeks | fat free mass (% and kg), fatt mass (% and in kg) |
| Changes in metabolome plasma profile | Measured at baseline and after 4 weeks | concentration of amino acids in blood |
| Changes in body weight | Measured at baseline and after 4 weeks | Weight (kg) measured by digital scale |
| Changes in body mass index (BMI) | Measured at baseline and after 4 weeks | Measured as body weight in kg/height in meter2 ( kg/m2) |
| Changes in physical performance | Measured at baseline and after 4 weeks | Short Physical Performance Battery (SPPB) test (includes balance test, chair test (sit to stand) and walk test) |
| Changes in satiety hormones | Measured at baseline and after 4 weeks | e.g. concentration of serum ghrelin, amylin, leptin |
Countries
Norway
Outcome results
None listed