NCT04606628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

October 15, 2020

Last Update Submit

January 5, 2022

Conditions

HealthyInflammationAging

Keywords

Eggshell membraneHealthy volunteersOld volunteers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Changes in body composition - measured by Bioimpedance (BIA)

    Measured at baseline and after 4 weeks

  • Change in muscle strength

    Measured at baseline and after 4 weeks

  • Changes in markers related to lipid metabolism

    Measured at baseline and after 4 weeks

  • Peripheral blood mononuclear cell (PBMC) gene expression

    Measured at baseline and after 4 weeks

  • Change in microbiota composition (optional)

    Measured at baseline and after 4 weeks

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Eggshell membrane (ESM)

Placebo

EXPERIMENTAL

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

Other: Placebo

Interventions

Eggshell membrane (ESM)OTHER

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

Intervention
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age70 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stine M Ulven, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a randomized double-blinded controlled trial and is considered as a pilot study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 28, 2020

Study Start

October 15, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

NO(1)