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Optimal Value Increase of Egg Products (OPTIEgg)

Primary Purpose

Healthy, Inflammation, Aging

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Eggshell membrane (ESM)
Placebo
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Eggshell membrane, Healthy volunteers, Old volunteers

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

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 %

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Placebo

Arm Description

Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks.

Participants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks.

Outcomes

Primary Outcome Measures

Change in plasma levels of inflammatory markers
concentration of C-reactive protein (CRP)
Change in plasma levels of inflammatory markers
concentration of TNFalpha

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2020
Last Updated
January 5, 2022
Sponsor
University of Oslo
Collaborators
Nofima, Norwegian University of Life Sciences, Nortuna, Norilia, Orkla, Danægg
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1. Study Identification

Unique Protocol Identification Number
NCT04606628
Brief Title
Optimal Value Increase of Egg Products
Acronym
OPTIEgg
Official Title
OPTIEgg- Optimal Value Increase of Egg Products
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Nofima, Norwegian University of Life Sciences, Nortuna, Norilia, Orkla, Danægg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Inflammation, Aging
Keywords
Eggshell membrane, Healthy volunteers, Old volunteers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks.
Intervention Type
Other
Intervention Name(s)
Eggshell membrane (ESM)
Intervention Description
The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks
Primary Outcome Measure Information:
Title
Change in plasma levels of inflammatory markers
Description
concentration of C-reactive protein (CRP)
Time Frame
Measured at baseline and after 4 weeks (end of study)
Title
Change in plasma levels of inflammatory markers
Description
concentration of TNFalpha
Time Frame
Measured at baseline and after 4 weeks (end of study)
Secondary Outcome Measure Information:
Title
Changes in body composition - measured by Bioimpedance (BIA)
Description
fat free mass (% and kg), fatt mass (% and in kg)
Time Frame
Measured at baseline and after 4 weeks
Title
Change in muscle strength
Description
Measured by grip strength
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in markers related to lipid metabolism
Description
Blood concentrations of e.g. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses
Time Frame
Measured at baseline and after 4 weeks
Title
Peripheral blood mononuclear cell (PBMC) gene expression
Description
mRNA levels of of genes involved in lipid metabolism and inflammation
Time Frame
Measured at baseline and after 4 weeks
Title
Change in microbiota composition (optional)
Description
Consenctration of faecal short-chain fatty acids
Time Frame
Measured at baseline and after 4 weeks
Title
Change in microbiota composition (optional)
Description
bacteria type and diversity
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in satiety hormones
Description
e.g. concentration of serum ghrelin, amylin, leptin
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in metabolome plasma profile
Description
concentration of amino acids in blood
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in metabolome plasma profile
Description
concentration of low molecular molecules in blood
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in body weight
Description
Weight (kg) measured by digital scale
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in body mass index (BMI)
Description
Measured as body weight in kg/height in meter2 ( kg/m2)
Time Frame
Measured at baseline and after 4 weeks
Title
Changes in physical performance
Description
Short Physical Performance Battery (SPPB) test (includes balance test, chair test (sit to stand) and walk test)
Time Frame
Measured at baseline and after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 %
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stine M Ulven, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway

12. IPD Sharing Statement

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Optimal Value Increase of Egg Products

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