Fermented Dairy Products and The Metabolic Syndrome (FerMetS)

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: Completed
• Conditions: Metabolic Syndrome; Overweight or Obesity
• Intervention / Treatment: Dietary supplement: Regular whole milk; Dietary supplement: Yogurt with live bacteria; Dietary supplement: Yogurt with inactivated bacteria; Dietary supplement: Acidified whole milk

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Liver fat	Measurements of liver fat by Magnetic Resonance Imaging	Change from Week 0 to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiometabolic risk	Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions	Change from Week 0 to week 16
Cardiometabolic risk	Measured by fasting ALAT	Change from Week 0 to week 16
Cardiometabolic risk	Measured by fasting blood pressure (automatic device)	Change from Week 0 to week 16
Gut microbiome	Measurments of microbiota (fecal spot samples)	Change from week -4 to week 16
Glucose metabolism (fasting samples)	Measurements of fasting glucose, insulin, C-peptide, HbA1C	Change from Week 0 to week 16
Glucose metabolism (5 hour oral glucose tolerance test)	Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test	Week 16 (5 hour test)
Inflammation	Measurements of fasting CRP	Change from Week 0 to week 16
Inflammation	Measurements of fasting IL-6	Change from Week 0 to week 16
Inflammation	Measurements of fasting TNF-alfa	Change from Week 0 to week 16
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).	Change from week -4 to week 16
Fat disposition and pancreatic fat	Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging	Change from Week 0 to week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolome	Measurement of metabolomic markers in blood, urine and feces	Change from week -4 to week 16
Physical activity	Measured by International Physical Activity Questionnaire (IPAQ)	Change from week -4 to week 16
Sleep quality	Measured by Pittsburg Sleep Quality Index (PSQI)	Change from week -4 to week 16
Perceived stress	Measured by Perceived Stress Scale (PSS)	Change from week -4 to week 16
Life quality	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	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	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	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

• Sponsor: Faidon Magkos
• Collaborators: University of Aarhus; Arla Food for Health; Mælkeafgiftsfonden; University of Copenhagen, Department of Biology
• Investigators: Principal Investigator: Faidon Magkos, PhD, University of Copenhagen, Department of Nutrition, Exercise and Sports

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Dairy; Glucose metabolism; Liver fat
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Overweight
• Other Study ID 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