Clinical trial NCT04755530: Fermented Dairy Products and The Metabolic Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Metabolic Syndrome
Keywords: Dairy
Liver fat
Glucose metabolism
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Arla Food for Health
name: University of Aarhus
name: Mælkeafgiftsfonden
name: University of Copenhagen, Department of Biology
First posted: 2021-02-16
Enrollment: 100
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 16-week parallel randomized controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Liver fat
timeFrame: Change from Week 0 to week 16
Secondary outcomes:
measure: Cardiometabolic risk
timeFrame: Change from Week 0 to week 16
measure: Cardiometabolic risk
timeFrame: Change from Week 0 to week 16
measure: Cardiometabolic risk
timeFrame: Change from Week 0 to week 16
measure: Gut microbiome
timeFrame: Change from week -4 to week 16
measure: Glucose metabolism (fasting samples)
timeFrame: Change from Week 0 to week 16
measure: Glucose metabolism (5 hour oral glucose tolerance test)
timeFrame: Week 16 (5 hour test)
measure: Inflammation
timeFrame: Change from Week 0 to week 16
measure: Inflammation
timeFrame: Change from Week 0 to week 16
measure: Inflammation
timeFrame: Change from Week 0 to week 16
measure: Body composition
timeFrame: Change from week -4 to week 16
measure: Fat disposition and pancreatic fat
timeFrame: Change from Week 0 to week 16
Other outcomes:
measure: Metabolome
timeFrame: Change from week -4 to week 16
measure: Physical activity
timeFrame: Change from week -4 to week 16
measure: Sleep quality
timeFrame: Change from week -4 to week 16
measure: Perceived stress
timeFrame: Change from week -4 to week 16
measure: Life quality
timeFrame: Change from week -4 to week 16
measure: The influence of initial glucose metabolism
timeFrame: Change from week -4 to week 16
measure: The influence of initial gut microbiota
timeFrame: Change from week -4 to week 16
measure: The influence of initial body composition
timeFrame: Change from week -4 to week 16
Locations:
city: Frederiksberg
country: Denmark
facility: University of Copenhagen, Department of Nutrition, Exercise and Sports
state: DK
Study officials:
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
name: Faidon Magkos, PhD
role: PRINCIPAL_INVESTIGATOR
References: