HealthyOPTIEggNCT04606628
Optimal Value Increase of Egg Products
A study testing Eggshell membrane (ESM) in people with Healthy and Inflammation, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 70 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Inflammation, Aging
- What is being tested?
- Eggshell membrane (ESM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Unwilling to perform physical tests
- Eligibility
- Diabetes type I or II, HbA1c ≥ 6.5 %
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy, Inflammation, Aging
- Being tested
- Eggshell membrane (ESM), Placebo
- Keywords
- Eggshell membrane, Healthy volunteers, Old volunteers
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eggshell membrane (ESM)Other
The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.
PlaceboOther
The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks. Receives: Other: Eggshell membrane (ESM) |
| Placebo | Experimental | Participants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma levels of inflammatory markers
concentration of C-reactive protein (CRP)
Measured: Measured at baseline and after 4 weeks (end of study)
Change in plasma levels of inflammatory markers
concentration of TNFalpha
Measured: Measured at baseline and after 4 weeks (end of study)
Secondary outcomes (12)
Changes in body composition - measured by Bioimpedance (BIA)
fat free mass (% and kg), fatt mass (% and in kg)
Measured: Measured at baseline and after 4 weeks
Change in muscle strength
Measured by grip strength
Measured: 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: 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: Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
Consenctration of faecal short-chain fatty acids
Measured: Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
bacteria type and diversity
Measured: Measured at baseline and after 4 weeks
Changes in satiety hormones
e.g. concentration of serum ghrelin, amylin, leptin
Measured: Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
concentration of amino acids in blood
Measured: Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
concentration of low molecular molecules in blood
Measured: Measured at baseline and after 4 weeks
Changes in body weight
Weight (kg) measured by digital scale
Measured: 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: 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: Measured at baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start15 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized double-blinded controlled trial and is considered as a pilot study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Nofima, Norwegian University of Life Sciences, Nortuna, Norilia, Orkla, Danægg
- Responsible party
- Principal investigator, Stine Marie Ulven, University of Oslo
- Investigators
- Stine M Ulven, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606628
- Sponsor's protocol ID
- 2020/95084/REK Sør-Øst
- Acronym
- OPTIEgg
- Status last verified
- Jan 2022
- First submitted
- 15 Oct 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIEgg- Optimal Value Increase of Egg Products
- ClinicalTrials.gov ID
- NCT04606628
- Acronym / sponsor ID
- OPTIEgg / 2020/95084/REK Sør-Øst
- Conditions
- Healthy, Inflammation, Aging
- Keywords
- Eggshell membrane, Healthy volunteers, Old volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Nofima, Norwegian University of Life Sciences, Nortuna, Norilia, Orkla, Danægg
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized double-blinded controlled trial and is considered as a pilot study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Eggshell membrane (ESM)Participants will consume 2 capsules containing eggshell membrane(ESM) with breakfast every day in 4 weeks. |
| Placebo | Experimental | Other: PlaceboParticipants will consume 2 capsules with no bioactive substance (placebo) with breakfast every day in 4 weeks. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eggshell membrane (ESM)The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks. | Other | Intervention |
| PlaceboThe placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks | Other | Placebo |
Primary outcome
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)
Change in plasma levels of inflammatory markers
Time frame: Measured at baseline and after 4 weeks (end of study)
concentration of TNFalpha
12 secondary outcomes
Changes in body composition - measured by Bioimpedance (BIA)
Time frame: Measured at baseline and after 4 weeks
Change in muscle strength
Time frame: Measured at baseline and after 4 weeks
Changes in markers related to lipid metabolism
Time frame: Measured at baseline and after 4 weeks
Peripheral blood mononuclear cell (PBMC) gene expression
Time frame: Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
Time frame: Measured at baseline and after 4 weeks
Change in microbiota composition (optional)
Time frame: Measured at baseline and after 4 weeks
Changes in satiety hormones
Time frame: Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
Time frame: Measured at baseline and after 4 weeks
Changes in metabolome plasma profile
Time frame: Measured at baseline and after 4 weeks
Changes in body weight
Time frame: Measured at baseline and after 4 weeks
Changes in body mass index (BMI)
Time frame: Measured at baseline and after 4 weeks
Changes in physical performance
Time frame: Measured at baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine M Ulven, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggshell membrane (ESM) in people with Healthy and Inflammation, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma levels of inflammatory markers (time frame: Measured at baseline and after 4 weeks (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.