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CompletedNCT04606628OPTIEggUpdated Jan 21, 2022

Optimal Value Increase of Egg Products

An interventional study of Eggshell membrane (ESM) and Placebo in Healthy, Inflammation and Aging, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 70 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by University of Oslo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
70 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Inflammation
  • Aging

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Keywords

  • Eggshell membrane
  • Healthy volunteers
  • Old volunteers
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 57 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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 %
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Intervention

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

    Other: Eggshell membrane (ESM)

  • Experimental
    Placebo

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

    Other: Placebo

Interventions

  • OtherEggshell membrane (ESM)

    The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.

  • OtherPlacebo

    The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks

06

What researchers measure

Primary outcomes

  1. Change in plasma levels of inflammatory markers

    concentration of C-reactive protein (CRP)

    Time frame: Measured at baseline and after 4 weeks (end of study)

  2. Change in plasma levels of inflammatory markers

    concentration of TNFalpha

    Time frame: Measured at baseline and after 4 weeks (end of study)

Secondary outcomes

  1. Changes in body composition - measured by Bioimpedance (BIA)

    fat free mass (% and kg), fatt mass (% and in kg)

    Time frame: Measured at baseline and after 4 weeks

  2. Change in muscle strength

    Measured by grip strength

    Time frame: Measured at baseline and after 4 weeks

  3. Changes in markers related to lipid metabolism

    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

  4. Peripheral blood mononuclear cell (PBMC) gene expression

    mRNA levels of of genes involved in lipid metabolism and inflammation

    Time frame: Measured at baseline and after 4 weeks

  5. Change in microbiota composition (optional)

    Consenctration of faecal short-chain fatty acids

    Time frame: Measured at baseline and after 4 weeks

  6. Change in microbiota composition (optional)

    bacteria type and diversity

    Time frame: Measured at baseline and after 4 weeks

  7. Changes in satiety hormones

    e.g. concentration of serum ghrelin, amylin, leptin

    Time frame: Measured at baseline and after 4 weeks

  8. Changes in metabolome plasma profile

    concentration of amino acids in blood

    Time frame: Measured at baseline and after 4 weeks

  9. Changes in metabolome plasma profile

    concentration of low molecular molecules in blood

    Time frame: Measured at baseline and after 4 weeks

  10. Changes in body weight

    Weight (kg) measured by digital scale

    Time frame: Measured at baseline and after 4 weeks

  11. Changes in body mass index (BMI)

    Measured as body weight in kg/height in meter2 ( kg/m2)

    Time frame: Measured at baseline and after 4 weeks

  12. Changes in physical performance

    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

07

Study locations

1 site
  • University of Oslo
    Oslo, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04606628
Lead sponsor
University of Oslo
Collaborators
Nofima, Norwegian University of Life Sciences, Nortuna, Norilia, Orkla, Danægg
Responsible party
Stine Marie Ulven (Professor, University of Oslo) — Principal investigator
First posted
Oct 28, 2020
Start date
Oct 15, 2020
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Jan 21, 2022

Study contacts

Stine M Ulven, PhD
principal investigator · University of Oslo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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