Optimal Value Increase of Egg Products (OPTIEgg)

OPTIEgg- Optimal Value Increase of Egg Products

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Healthy; Aging
• Intervention / Treatment: Other: Eggshell membrane (ESM); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years to 98 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 %

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Nofima; Norwegian University of Life Sciences; Nortuna; Norilia; Orkla; Danægg
• Investigators: Principal Investigator: Stine M Ulven, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Healthy volunteers; Eggshell membrane; Old volunteers
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2020/95084/REK Sør-Øst

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No