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Completed

NCT Number: NCT04606628

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.

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Key information

Conditions

Healthy Aging Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

Eggshell membrane (ESM)

Other

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

Placebo

Other

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

Primary outcomes

  1. 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)

  2. Change in plasma levels of inflammatory markers

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

    concentration of TNFalpha

Secondary outcomes

  1. 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)

  2. Change in muscle strength

    Time frame: Measured at baseline and after 4 weeks

    Measured by grip strength

  3. 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

  4. 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

  5. Change in microbiota composition (optional)

    Time frame: Measured at baseline and after 4 weeks

    Consenctration of faecal short-chain fatty acids

  6. Change in microbiota composition (optional)

    Time frame: Measured at baseline and after 4 weeks

    bacteria type and diversity

  7. Changes in satiety hormones

    Time frame: Measured at baseline and after 4 weeks

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

  8. Changes in metabolome plasma profile

    Time frame: Measured at baseline and after 4 weeks

    concentration of amino acids in blood

  9. Changes in metabolome plasma profile

    Time frame: Measured at baseline and after 4 weeks

    concentration of low molecular molecules in blood

  10. Changes in body weight

    Time frame: Measured at baseline and after 4 weeks

    Weight (kg) measured by digital scale

  11. 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)

  12. 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)

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Danægg
  • Nofima
  • Norilia
  • Nortuna
  • Norwegian University of Life Sciences
  • Orkla

Registry information

Official study title

OPTIEgg- Optimal Value Increase of Egg Products

Acronym: OPTIEgg

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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