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Overweight or ObesityFerMetSNCT04755530

Fermented Dairy Products and The Metabolic Syndrome

A study testing Regular whole milk, Yogurt with live bacteria and Yogurt with inactivated bacteria in people with Overweight or Obesity and Metabolic Syndrome, run by Faidon Magkos at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Overweight or Obesity, Metabolic Syndrome
What is being tested?
Regular whole milk, Yogurt with live bacteria and Yogurt with inactivated bacteria
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteDenmark
Study dates
25 Feb 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen, Department of Nutrition, Exercise and Sports

    Frederiksberg, DK, 1958

Other trials in Denmark

About this study

Official title: 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.

Being tested
Regular whole milk, Yogurt with live bacteria, Yogurt with inactivated bacteria, Acidified whole milk
Keywords
Dairy, Liver fat, Glucose metabolism
Medical subject headings
Overweight, Obesity, Metabolic Syndrome, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular whole milkDietary supplement

    Also called Dairy product, Milk

    400 g/day of regular whole milk

  • Yogurt with live bacteriaDietary supplement

    Also called Fermented dairy product, Yogurt

    400 g/day of yogurt with live bacteria

  • Yogurt with inactivated bacteriaDietary supplement

    Also called Fermented dairy product, Yogurt

    400 g/day of yogurt with inactivated bacteria

  • Acidified whole milkDietary supplement

    Also called Dairy product

    400 g/day of yogurt with acidified whole milk

Study groups in NCT04755530
Study groupRoleWhat they receive
Regular whole milkActive comparatorSubstitution of a part of the habitual diet with 400 g/day of regular whole milk
Receives: Dietary Supplement: Regular whole milk
Yogurt with live bacteriaExperimentalSubstitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria
Receives: Dietary Supplement: Yogurt with live bacteria
Yogurt with inactivated bacteriaExperimentalSubstitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria
Receives: Dietary Supplement: Yogurt with inactivated bacteria
Acidified whole milkExperimentalSubstitution of a part of the habitual diet with 400 g/day of acidified whole milk
Receives: Dietary Supplement: Acidified whole milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver fat

    Measurements of liver fat by Magnetic Resonance Imaging

    Measured: Change from Week 0 to week 16

Secondary outcomes (11)

  1. Cardiometabolic risk

    Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions

    Measured: Change from Week 0 to week 16

  2. Cardiometabolic risk

    Measured by fasting ALAT

    Measured: Change from Week 0 to week 16

  3. Cardiometabolic risk

    Measured by fasting blood pressure (automatic device)

    Measured: Change from Week 0 to week 16

  4. Gut microbiome

    Measurments of microbiota (fecal spot samples)

    Measured: Change from week -4 to week 16

  5. Glucose metabolism (fasting samples)

    Measurements of fasting glucose, insulin, C-peptide, HbA1C

    Measured: Change from Week 0 to week 16

  6. Glucose metabolism (5 hour oral glucose tolerance test)

    Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test

    Measured: Week 16 (5 hour test)

  7. Inflammation

    Measurements of fasting CRP

    Measured: Change from Week 0 to week 16

  8. Inflammation

    Measurements of fasting IL-6

    Measured: Change from Week 0 to week 16

  9. Inflammation

    Measurements of fasting TNF-alfa

    Measured: Change from Week 0 to week 16

  10. Body composition

    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).

    Measured: Change from week -4 to week 16

  11. Fat disposition and pancreatic fat

    Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging

    Measured: Change from Week 0 to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start25 Feb 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
16-week parallel randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04755530
Sponsor's protocol ID
B363
Other IDs
H-20059243
Acronym
FerMetS
Status last verified
Feb 2023
First submitted
10 Feb 2021
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Correia BSB, Sandby K, Krarup T, Magkos F, Geiker NRW, Bertram HC. Changes in Plasma, Urine, and Fecal Metabolome after 16 Weeks of Consuming Dairy With Different Food Matrixes - A Randomized Controlled Trial. Mol Nutr Food Res. 2024 Mar;68(5):e2300363. doi: 10.1002/mnfr.202300363. Epub 2024 Feb 1.

    PubMed 38299443

  • Sandby K, Magkos F, Chabanova E, Petersen ET, Krarup T, Bertram HC, Kristiansen K, Geiker NRW. The effect of dairy products on liver fat and metabolic risk markers in males with abdominal obesity - a four-arm randomized controlled trial. Clin Nutr. 2024 Feb;43(2):534-542. doi: 10.1016/j.clnu.2023.12.018. Epub 2023 Dec 27.

    PubMed 38232682

Questions about this trial

What is this clinical trial studying?

A study testing Regular whole milk, Yogurt with live bacteria and Yogurt with inactivated bacteria in people with Overweight or Obesity and Metabolic Syndrome, run by Faidon Magkos at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver fat (time frame: Change from Week 0 to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04755530, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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