Optimal Value Increase of Egg Products

Study Overview
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Brief Summary
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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.

Official Title
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OPTIEgg- Optimal Value Increase of Egg Products

Conditions
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Healthy, Inflammation, Aging

Intervention / Treatment
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* Other: Eggshell membrane (ESM)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 %

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks. | Other: Eggshell membrane (ESM)<br>* The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.<br>|
| Experimental: Placebo<br>Participants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks. | Other: Placebo<br>* The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma levels of inflammatory markers | concentration of C-reactive protein (CRP) | Measured at baseline and after 4 weeks (end of study) | 
| Change in plasma levels of inflammatory markers | concentration of TNFalpha | Measured at baseline and after 4 weeks (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition - measured by Bioimpedance (BIA) | fat free mass (% and kg), fatt mass (% and in kg) | Measured at baseline and after 4 weeks | 
| Change in muscle strength | Measured by grip strength | Measured at baseline and after 4 weeks | 
| Changes in markers related to lipid metabolism | Blood concentrations of e.g. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses | Measured at baseline and after 4 weeks | 
| Peripheral blood mononuclear cell (PBMC) gene expression | mRNA levels of of genes involved in lipid metabolism and inflammation | Measured at baseline and after 4 weeks | 
| Change in microbiota composition (optional) | Consenctration of faecal short-chain fatty acids | Measured at baseline and after 4 weeks | 
| Change in microbiota composition (optional) | bacteria type and diversity | Measured at baseline and after 4 weeks | 
| Changes in satiety hormones | e.g. concentration of serum ghrelin, amylin, leptin | Measured at baseline and after 4 weeks | 
| Changes in metabolome plasma profile | concentration of amino acids in blood | Measured at baseline and after 4 weeks | 
| Changes in metabolome plasma profile | concentration of low molecular molecules in blood | Measured at baseline and after 4 weeks | 
| Changes in body weight | Weight (kg) measured by digital scale | Measured at baseline and after 4 weeks | 
| Changes in body mass index (BMI) | Measured as body weight in kg/height in meter2 ( kg/m2) | Measured at baseline and after 4 weeks | 
| Changes in physical performance | Short Physical Performance Battery (SPPB) test (includes balance test, chair test (sit to stand) and walk test) | Measured at baseline and after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eggshell membrane, Healthy volunteers, Old volunteers