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Completed

NCT Number: NCT04755530

Fermented Dairy Products and The 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.

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Key information

Conditions

Overweight or Obesity Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Nutrition, Exercise and Sports

Frederiksberg, DK, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular whole milk

Dietary Supplement

400 g/day of regular whole milk

Other names: Dairy product, Milk

Yogurt with live bacteria

Dietary Supplement

400 g/day of yogurt with live bacteria

Other names: Fermented dairy product, Yogurt

Yogurt with inactivated bacteria

Dietary Supplement

400 g/day of yogurt with inactivated bacteria

Other names: Fermented dairy product, Yogurt

Acidified whole milk

Dietary Supplement

400 g/day of yogurt with acidified whole milk

Other names: Dairy product

Primary outcomes

  1. Liver fat

    Time frame: Change from Week 0 to week 16

    Measurements of liver fat by Magnetic Resonance Imaging

Secondary outcomes

  1. Cardiometabolic risk

    Time frame: Change from Week 0 to week 16

    Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions

  2. Cardiometabolic risk

    Time frame: Change from Week 0 to week 16

    Measured by fasting ALAT

  3. Cardiometabolic risk

    Time frame: Change from Week 0 to week 16

    Measured by fasting blood pressure (automatic device)

  4. Gut microbiome

    Time frame: Change from week -4 to week 16

    Measurments of microbiota (fecal spot samples)

  5. Glucose metabolism (fasting samples)

    Time frame: Change from Week 0 to week 16

    Measurements of fasting glucose, insulin, C-peptide, HbA1C

  6. Glucose metabolism (5 hour oral glucose tolerance test)

    Time frame: Week 16 (5 hour test)

    Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test

  7. Inflammation

    Time frame: Change from Week 0 to week 16

    Measurements of fasting CRP

  8. Inflammation

    Time frame: Change from Week 0 to week 16

    Measurements of fasting IL-6

  9. Inflammation

    Time frame: Change from Week 0 to week 16

    Measurements of fasting TNF-alfa

  10. Body composition

    Time frame: 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).

  11. Fat disposition and pancreatic fat

    Time frame: Change from Week 0 to week 16

    Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging

Other outcomes

  1. Metabolome

    Time frame: Change from week -4 to week 16

    Measurement of metabolomic markers in blood, urine and feces

  2. Physical activity

    Time frame: Change from week -4 to week 16

    Measured by International Physical Activity Questionnaire (IPAQ)

  3. Sleep quality

    Time frame: Change from week -4 to week 16

    Measured by Pittsburg Sleep Quality Index (PSQI)

  4. Perceived stress

    Time frame: Change from week -4 to week 16

    Measured by Perceived Stress Scale (PSS)

  5. Life quality

    Time frame: Change from week -4 to week 16

    Measured by Physical and mental life quality, Short Form-36 (SF-36)

  6. The influence of initial glucose metabolism

    Time frame: Change from week -4 to week 16

    Statistical investigation of the effect of initial glucose metabolism on liver fat

  7. The influence of initial gut microbiota

    Time frame: Change from week -4 to week 16

    Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat

  8. The influence of initial body composition

    Time frame: Change from week -4 to week 16

    Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat

Sponsors and collaborators

Lead sponsor

Faidon Magkos

Other

Collaborators

  • Arla Foods
  • Mælkeafgiftsfonden
  • University of Aarhus
  • University of Copenhagen

Registry information

Official study title

Matrix Characterization and Effects of Fermented Dairy Products on Liver Fat, Cardiometabolic Risk and Gut Microbiome in Males With Symptoms of Metabolic Syndrome

Acronym: FerMetS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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