Fermented Dairy Products and The Metabolic Syndrome (FerMetS)

February 27, 2023 updated by: Faidon Magkos

Matrix Characterization and Effects of Fermented Dairy Products on Liver Fat, Cardiometabolic Risk and Gut Microbiome in Males With Symptoms of Metabolic Syndrome

The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Frederiksberg, DK, Denmark, 1958
        • University of Copenhagen, Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Age between 30-70 years
  • BMI of 28-45 kg/m2
  • Abdominal obesity (defined as waist circumference >102 cm)
  • Provided voluntary written informed consent

Exclusion Criteria:

  • Body weight changes +/- 5% in the past three months
  • Any diet, allergy or intolerance which results in not being able to follow the study protocol
  • Contraindications related to MRI (pacemaker, stent, magnitic metal in the body, claustrophobia, physiological diseases or a body weight >160 kg)
  • History or diagnosis of diabetes
  • History or diagnosis of heart, liver, gastrointestinal or kidney disease
  • History or diagnosis of illness related to energy balance
  • History or diagnosis of eating disorders
  • Simultaneous blood donation for other purpose than this study (and one month before initiating the study)
  • Simultaneous participation in other clinical intervention studies
  • Any other condition that judged by the investgator may interfere with the adherence to the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Regular whole milk
Substitution of a part of the habitual diet with 400 g/day of regular whole milk
Dietary supplement: Regular whole milk
400 g/day of regular whole milk
Other Names:
  • Milk
  • Dairy product
Experimental: Yogurt with live bacteria
Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria
Dietary supplement: Yogurt with live bacteria
400 g/day of yogurt with live bacteria
Other Names:
  • Fermented dairy product
  • Yogurt
Experimental: Yogurt with inactivated bacteria
Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria
Dietary supplement: Yogurt with inactivated bacteria
400 g/day of yogurt with inactivated bacteria
Other Names:
  • Fermented dairy product
  • Yogurt
Experimental: Acidified whole milk
Substitution of a part of the habitual diet with 400 g/day of acidified whole milk
Dietary supplement: Acidified whole milk
400 g/day of yogurt with acidified whole milk
Other Names:
  • Dairy product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Liver fat
Time Frame: Change from Week 0 to week 16
Measurements of liver fat by Magnetic Resonance Imaging
Change from Week 0 to week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk
Time Frame: Change from Week 0 to week 16
Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions
Change from Week 0 to week 16
Cardiometabolic risk
Time Frame: Change from Week 0 to week 16
Measured by fasting ALAT
Change from Week 0 to week 16
Cardiometabolic risk
Time Frame: Change from Week 0 to week 16
Measured by fasting blood pressure (automatic device)
Change from Week 0 to week 16
Gut microbiome
Time Frame: Change from week -4 to week 16
Measurments of microbiota (fecal spot samples)
Change from week -4 to week 16
Glucose metabolism (fasting samples)
Time Frame: Change from Week 0 to week 16
Measurements of fasting glucose, insulin, C-peptide, HbA1C
Change from Week 0 to week 16
Glucose metabolism (5 hour oral glucose tolerance test)
Time Frame: Week 16 (5 hour test)
Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test
Week 16 (5 hour test)
Inflammation
Time Frame: Change from Week 0 to week 16
Measurements of fasting CRP
Change from Week 0 to week 16
Inflammation
Time Frame: Change from Week 0 to week 16
Measurements of fasting IL-6
Change from Week 0 to week 16
Inflammation
Time Frame: Change from Week 0 to week 16
Measurements of fasting TNF-alfa
Change from Week 0 to week 16
Body composition
Time Frame: Change from week -4 to week 16
Measurements of body weight (every week), height (stadiometer) (only at screening), waist and hip circumference (non-elastic tape), sagittal diameter (abdominal caliper) (only week 0 and 16) as wells as fat mass and fat free mass (whole body DXA scan) (only week 0 and 16).
Change from week -4 to week 16
Fat disposition and pancreatic fat
Time Frame: Change from Week 0 to week 16
Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging
Change from Week 0 to week 16

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolome
Time Frame: Change from week -4 to week 16
Measurement of metabolomic markers in blood, urine and feces
Change from week -4 to week 16
Physical activity
Time Frame: Change from week -4 to week 16
Measured by International Physical Activity Questionnaire (IPAQ)
Change from week -4 to week 16
Sleep quality
Time Frame: Change from week -4 to week 16
Measured by Pittsburg Sleep Quality Index (PSQI)
Change from week -4 to week 16
Perceived stress
Time Frame: Change from week -4 to week 16
Measured by Perceived Stress Scale (PSS)
Change from week -4 to week 16
Life quality
Time Frame: Change from week -4 to week 16
Measured by Physical and mental life quality, Short Form-36 (SF-36)
Change from week -4 to week 16
The influence of initial glucose metabolism
Time Frame: Change from week -4 to week 16
Statistical investigation of the effect of initial glucose metabolism on liver fat
Change from week -4 to week 16
The influence of initial gut microbiota
Time Frame: Change from week -4 to week 16
Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat
Change from week -4 to week 16
The influence of initial body composition
Time Frame: Change from week -4 to week 16
Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat
Change from week -4 to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faidon Magkos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus
Arla Food for Health
Mælkeafgiftsfonden
University of Copenhagen, Department of Biology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Faidon Magkos, PhD, University of Copenhagen, Department of Nutrition, Exercise and Sports

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B363
  • H-20059243 (Registry Identifier: Danish Ethical Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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