FerMetS: Fermented Dairy Products and The Metabolic Syndrome

Sponsor

Nina Rica Wium Geiker (Other)

Overall Status

Completed

CT.gov ID

NCT04755530

Collaborator

Arla Food for Health (Other), University of Aarhus (Other), Mælkeafgiftsfonden (Other), University of Copenhagen, Department of Biology (Other)

100

Enrollment

Location

Arms

16.1

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight or Obesity Metabolic Syndrome	Dietary Supplement: Regular whole milk Dietary Supplement: Yogurt with live bacteria Dietary Supplement: Yogurt with inactivated bacteria Dietary Supplement: Acidified whole milk	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

16-week parallel randomized controlled trial16-week parallel randomized controlled trial

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Until the statistical analyses are performed, principal investigator and statistician are blinded

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 25, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

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: Dairy product Milk
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

Outcome Measures

Primary Outcome Measures

Liver fat [Change from Week 0 to week 16]
Measurements of liver fat by Magnetic Resonance Imaging

Secondary Outcome Measures

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

Other Outcome Measures

Metabolome [Change from week -4 to week 16]
Measurement of metabolomic markers in blood, urine and feces
Physical activity [Change from week -4 to week 16]
Measured by International Physical Activity Questionnaire (IPAQ)
Sleep quality [Change from week -4 to week 16]
Measured by Pittsburg Sleep Quality Index (PSQI)
Perceived stress [Change from week -4 to week 16]
Measured by Perceived Stress Scale (PSS)
Life quality [Change from week -4 to week 16]
Measured by Physical and mental life quality, Short Form-36 (SF-36)
The influence of initial glucose metabolism [Change from week -4 to week 16]
Statistical investigation of the effect of initial glucose metabolism on liver fat
The influence of initial gut microbiota [Change from week -4 to week 16]
Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat
The influence of initial body composition [Change from week -4 to week 16]
Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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