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Fermented Dairy Products and The Metabolic Syndrome (FerMetS)

Primary Purpose

Overweight or Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Regular whole milk
Yogurt with live bacteria
Yogurt with inactivated bacteria
Acidified whole milk
Sponsored by
Faidon Magkos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight or Obesity focused on measuring Dairy, Liver fat, Glucose metabolism

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Regular whole milk

Yogurt with live bacteria

Yogurt with inactivated bacteria

Acidified whole milk

Arm Description

Substitution of a part of the habitual diet with 400 g/day of regular whole milk

Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria

Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria

Substitution of a part of the habitual diet with 400 g/day of acidified whole milk

Outcomes

Primary Outcome Measures

Liver fat
Measurements of liver fat by Magnetic Resonance Imaging

Secondary Outcome Measures

Cardiometabolic risk
Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions
Cardiometabolic risk
Measured by fasting ALAT
Cardiometabolic risk
Measured by fasting blood pressure (automatic device)
Gut microbiome
Measurments of microbiota (fecal spot samples)
Glucose metabolism (fasting samples)
Measurements of fasting glucose, insulin, C-peptide, HbA1C
Glucose metabolism (5 hour oral glucose tolerance test)
Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test
Inflammation
Measurements of fasting CRP
Inflammation
Measurements of fasting IL-6
Inflammation
Measurements of fasting TNF-alfa
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).
Fat disposition and pancreatic fat
Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging

Full Information

First Posted
February 10, 2021
Last Updated
February 27, 2023
Sponsor
Faidon Magkos
Collaborators
Arla Food for Health, University of Aarhus, Mælkeafgiftsfonden, University of Copenhagen, Department of Biology
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1. Study Identification

Unique Protocol Identification Number
NCT04755530
Brief Title
Fermented Dairy Products and The Metabolic Syndrome
Acronym
FerMetS
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faidon Magkos
Collaborators
Arla Food for Health, University of Aarhus, Mælkeafgiftsfonden, University of Copenhagen, Department of Biology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity, Metabolic Syndrome
Keywords
Dairy, Liver fat, Glucose metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
16-week parallel randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Until the statistical analyses are performed, principal investigator and statistician are blinded
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular whole milk
Arm Type
Active Comparator
Arm Description
Substitution of a part of the habitual diet with 400 g/day of regular whole milk
Arm Title
Yogurt with live bacteria
Arm Type
Experimental
Arm Description
Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria
Arm Title
Yogurt with inactivated bacteria
Arm Type
Experimental
Arm Description
Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria
Arm Title
Acidified whole milk
Arm Type
Experimental
Arm Description
Substitution of a part of the habitual diet with 400 g/day of acidified whole milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Regular whole milk
Other Intervention Name(s)
Dairy product, Milk
Intervention Description
400 g/day of regular whole milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt with live bacteria
Other Intervention Name(s)
Fermented dairy product, Yogurt
Intervention Description
400 g/day of yogurt with live bacteria
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt with inactivated bacteria
Other Intervention Name(s)
Fermented dairy product, Yogurt
Intervention Description
400 g/day of yogurt with inactivated bacteria
Intervention Type
Dietary Supplement
Intervention Name(s)
Acidified whole milk
Other Intervention Name(s)
Dairy product
Intervention Description
400 g/day of yogurt with acidified whole milk
Primary Outcome Measure Information:
Title
Liver fat
Description
Measurements of liver fat by Magnetic Resonance Imaging
Time Frame
Change from Week 0 to week 16
Secondary Outcome Measure Information:
Title
Cardiometabolic risk
Description
Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions
Time Frame
Change from Week 0 to week 16
Title
Cardiometabolic risk
Description
Measured by fasting ALAT
Time Frame
Change from Week 0 to week 16
Title
Cardiometabolic risk
Description
Measured by fasting blood pressure (automatic device)
Time Frame
Change from Week 0 to week 16
Title
Gut microbiome
Description
Measurments of microbiota (fecal spot samples)
Time Frame
Change from week -4 to week 16
Title
Glucose metabolism (fasting samples)
Description
Measurements of fasting glucose, insulin, C-peptide, HbA1C
Time Frame
Change from Week 0 to week 16
Title
Glucose metabolism (5 hour oral glucose tolerance test)
Description
Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test
Time Frame
Week 16 (5 hour test)
Title
Inflammation
Description
Measurements of fasting CRP
Time Frame
Change from Week 0 to week 16
Title
Inflammation
Description
Measurements of fasting IL-6
Time Frame
Change from Week 0 to week 16
Title
Inflammation
Description
Measurements of fasting TNF-alfa
Time Frame
Change from Week 0 to week 16
Title
Body composition
Description
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).
Time Frame
Change from week -4 to week 16
Title
Fat disposition and pancreatic fat
Description
Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging
Time Frame
Change from Week 0 to week 16
Other Pre-specified Outcome Measures:
Title
Metabolome
Description
Measurement of metabolomic markers in blood, urine and feces
Time Frame
Change from week -4 to week 16
Title
Physical activity
Description
Measured by International Physical Activity Questionnaire (IPAQ)
Time Frame
Change from week -4 to week 16
Title
Sleep quality
Description
Measured by Pittsburg Sleep Quality Index (PSQI)
Time Frame
Change from week -4 to week 16
Title
Perceived stress
Description
Measured by Perceived Stress Scale (PSS)
Time Frame
Change from week -4 to week 16
Title
Life quality
Description
Measured by Physical and mental life quality, Short Form-36 (SF-36)
Time Frame
Change from week -4 to week 16
Title
The influence of initial glucose metabolism
Description
Statistical investigation of the effect of initial glucose metabolism on liver fat
Time Frame
Change from week -4 to week 16
Title
The influence of initial gut microbiota
Description
Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat
Time Frame
Change from week -4 to week 16
Title
The influence of initial body composition
Description
Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat
Time Frame
Change from week -4 to week 16

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Based on self-representation of gender identity
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faidon Magkos, PhD
Organizational Affiliation
University of Copenhagen, Department of Nutrition, Exercise and Sports
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Nutrition, Exercise and Sports
City
Frederiksberg
State/Province
DK
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

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Fermented Dairy Products and The Metabolic Syndrome

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