Optimal Value Increase of Egg Products (OPTIEgg)

January 5, 2022 updated by: Stine Marie Ulven, University of Oslo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

66 years to 96 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in plasma levels of inflammatory markers
Time Frame: Measured at baseline and after 4 weeks (end of study)
concentration of C-reactive protein (CRP)
Measured at baseline and after 4 weeks (end of study)
Change in plasma levels of inflammatory markers
Time Frame: Measured at baseline and after 4 weeks (end of study)
concentration of TNFalpha
Measured at baseline and after 4 weeks (end of study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body composition - measured by Bioimpedance (BIA)
Time Frame: Measured at baseline and after 4 weeks
fat free mass (% and kg), fatt mass (% and in kg)
Measured at baseline and after 4 weeks
Change in muscle strength
Time Frame: Measured at baseline and after 4 weeks
Measured by grip strength
Measured at baseline and after 4 weeks
Changes in markers related to lipid metabolism
Time Frame: Measured at baseline and after 4 weeks
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
Time Frame: Measured at baseline and after 4 weeks
mRNA levels of of genes involved in lipid metabolism and inflammation
Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
Time Frame: Measured at baseline and after 4 weeks
Consenctration of faecal short-chain fatty acids
Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
Time Frame: Measured at baseline and after 4 weeks
bacteria type and diversity
Measured at baseline and after 4 weeks
Changes in satiety hormones
Time Frame: Measured at baseline and after 4 weeks
e.g. concentration of serum ghrelin, amylin, leptin
Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
Time Frame: Measured at baseline and after 4 weeks
concentration of amino acids in blood
Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
Time Frame: Measured at baseline and after 4 weeks
concentration of low molecular molecules in blood
Measured at baseline and after 4 weeks
Changes in body weight
Time Frame: Measured at baseline and after 4 weeks
Weight (kg) measured by digital scale
Measured at baseline and after 4 weeks
Changes in body mass index (BMI)
Time Frame: Measured at baseline and after 4 weeks
Measured as body weight in kg/height in meter2 ( kg/m2)
Measured at baseline and after 4 weeks
Changes in physical performance
Time Frame: Measured at baseline and after 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nofima
Norwegian University of Life Sciences
Nortuna
Norilia
Orkla
Danægg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stine M Ulven, PhD, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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