Kefir Consumption on Various Parameters in Adults Subjects

NCT05715008 | Unknown

• 1 other identifier: UTH_Kefir
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the effect of kefir consumption on anthropometric, physiological and redox status parameters in adult subjects, and compare it with the intake of placebo drink (milk).

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (6)

• Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,2-diphenyl-1-picrylhydrazyl (DPPH) method.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in glutathione following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 5,5'-dithio-bis-(2-nitrobenzoic acid) (DTNB) method.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in uric acid following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in bilirubin following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in lipid peroxidation following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in protein carbonyls following 2 weeks of kefir consumption and placebo.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,4-Dinitrophenylhydrazine (DNPH) method.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Secondary Outcomes (12)

• Changes in body composition (in kg) following 2 weeks of kefir consumption and placebo.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• % Changes in body composition following 2 weeks of kefir consumption and placebo.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in body mass index following 2 weeks of kefir consumption and placebo.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in waist-to-hip ratio following 2 weeks of kefir consumption and placebo.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

• Changes in blood pressure following 2 weeks of kefir consumption and placebo.

  2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Study Arms (2)

Kefir consumption

EXPERIMENTAL

Kefir consumption (300ml/day) for 2 weeks in a counterbalanced manner to 16 adult subjects

Other: Kefir

Placebo (cow milk)

PLACEBO COMPARATOR

Placebo administration for 2 weeks in a counterbalanced manner to 16 adult subjects

Other: Placebo

Interventions

Kefir OTHER

Comparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects

Kefir consumption

Placebo OTHER

Comparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects

Placebo (cow milk)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The persons selected will be volunteers.
• The use of alcohol and smoking will be prohibited during the experiment.
• Participation in other sports activities will also not be allowed.
• In the last six months they should not have taken any medication that affect the redox status, as well as dietary supplements with antioxidants.
• Their blood pressure should be within normal limits.

You may not qualify if:

• Individuals with a past of health problems that are likely to have a negative effect on the indicators to be tested.
• Individuals with allergies.
• People with liver and gastric tract problems (e.g. ulcers).

Sponsors & Collaborators

• University of Thessaly: lead

MeSH Terms

Interventions

Kefir

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Athanasios Z Jamurtas, PhD

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

Athanasios Z Jamurtas, PhD

CONTACT

2431047054; ajamurt@pe.uth.gr

Marianna Chyta, BSc

CONTACT

6976895076; mchyta@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: February 6, 2023
• Study Start: January 30, 2023
• Primary Completion: March 30, 2023
• Study Completion: June 20, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02