Optimal Value Increase of Egg Products

Healthy Clinical Trial

— OPTIEgg  

Official title:

OPTIEgg- Optimal Value Increase of Egg Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606628
• Other study ID #: 2020/95084/REK Sør-Øst
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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 %

Related Conditions & MeSH terms

• Aging
• Healthy
• Inflammation

Intervention

Other:
• Eggshell membrane (ESM)
The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.
• Placebo
The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (7)

Lead Sponsor	Collaborator
University of Oslo	Danægg, Nofima, Norilia, Nortuna, Norwegian University of Life Sciences, Orkla

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma levels of inflammatory markers	concentration of C-reactive protein (CRP)	Measured at baseline and after 4 weeks (end of study)
Primary	Change in plasma levels of inflammatory markers	concentration of TNFalpha	Measured at baseline and after 4 weeks (end of study)
Secondary	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
Secondary	Change in muscle strength	Measured by grip strength	Measured at baseline and after 4 weeks
Secondary	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
Secondary	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
Secondary	Change in microbiota composition (optional)	Consenctration of faecal short-chain fatty acids	Measured at baseline and after 4 weeks
Secondary	Change in microbiota composition (optional)	bacteria type and diversity	Measured at baseline and after 4 weeks
Secondary	Changes in satiety hormones	e.g. concentration of serum ghrelin, amylin, leptin	Measured at baseline and after 4 weeks
Secondary	Changes in metabolome plasma profile	concentration of amino acids in blood	Measured at baseline and after 4 weeks
Secondary	Changes in metabolome plasma profile	concentration of low molecular molecules in blood	Measured at baseline and after 4 weeks
Secondary	Changes in body weight	Weight (kg) measured by digital scale	Measured at baseline and after 4 weeks
Secondary	Changes in body mass index (BMI)	Measured as body weight in kg/height in meter2 ( kg/m2)	Measured at baseline and after 4 weeks
Secondary	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