Clinical trial NCT04606628: Optimal Value Increase of Egg Products
Official title: OPTIEgg- Optimal Value Increase of Egg Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Inflammation
Aging
Keywords: Eggshell membrane
Healthy volunteers
Old volunteers
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Nofima
name: Norwegian University of Life Sciences
name: Nortuna
name: Norilia
name: Orkla
name: Danægg
First posted: 2020-10-28
Enrollment: 57
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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 %

Primary outcomes:
measure: Change in plasma levels of inflammatory markers
timeFrame: Measured at baseline and after 4 weeks (end of study)
measure: Change in plasma levels of inflammatory markers
timeFrame: Measured at baseline and after 4 weeks (end of study)
Secondary outcomes:
measure: Changes in body composition - measured by Bioimpedance (BIA)
timeFrame: Measured at baseline and after 4 weeks
measure: Change in muscle strength
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in markers related to lipid metabolism
timeFrame: Measured at baseline and after 4 weeks
measure: Peripheral blood mononuclear cell (PBMC) gene expression
timeFrame: Measured at baseline and after 4 weeks
measure: Change in microbiota composition (optional)
timeFrame: Measured at baseline and after 4 weeks
measure: Change in microbiota composition (optional)
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in satiety hormones
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in metabolome plasma profile
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in metabolome plasma profile
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in body weight
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in body mass index (BMI)
timeFrame: Measured at baseline and after 4 weeks
measure: Changes in physical performance
timeFrame: Measured at baseline and after 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Stine M Ulven, PhD
role: PRINCIPAL_INVESTIGATOR
References: