Metabolic Syndrome, Overweight or Obesity
Conditions
Keywords
Dairy, Liver fat, Glucose metabolism
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.
Interventions
DIETARY_SUPPLEMENTRegular whole milk
400 g/day of regular whole milk
DIETARY_SUPPLEMENTYogurt with live bacteria
400 g/day of yogurt with live bacteria
DIETARY_SUPPLEMENTYogurt with inactivated bacteria
400 g/day of yogurt with inactivated bacteria
DIETARY_SUPPLEMENTAcidified whole milk
400 g/day of yogurt with acidified whole milk
Sponsors
Arla Food for Health
University of Aarhus
Mælkeafgiftsfonden
University of Copenhagen, Department of Biology
Faidon Magkos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Until the statistical analyses are performed, principal investigator and statistician are blinded
Intervention model description
16-week parallel randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver fat | Change from Week 0 to week 16 | Measurements of liver fat by Magnetic Resonance Imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cardiometabolic risk | Change from Week 0 to week 16 | Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed