Fermented Dairy Products and The Metabolic Syndrome (FerMetS)

Faidon Magkos

Status: Completed

Conditions: Overweight or Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: Acidified whole milk; Dietary Supplement: Regular whole milk; Dietary Supplement: Yogurt with live bacteria; Dietary Supplement: Yogurt with inactivated bacteria

Study type: Interventional

Funder types: Other

Identifiers

NCT04755530

B363

H-20059243 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Regular whole milk

Active Comparator group

Description:

Substitution of a part of the habitual diet with 400 g/day of regular whole milk

Treatment:

Dietary Supplement: Regular whole milk

Yogurt with live bacteria

Experimental group

Description:

Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria

Treatment:

Dietary Supplement: Yogurt with live bacteria

Yogurt with inactivated bacteria

Experimental group

Description:

Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria

Treatment:

Dietary Supplement: Yogurt with inactivated bacteria

Acidified whole milk

Experimental group

Description:

Substitution of a part of the habitual diet with 400 g/day of acidified whole milk

Treatment:

Dietary Supplement: Acidified whole milk