Fermented Dairy Products and The Metabolic Syndrome

NCT04755530 | Completed

• 2 other identifiers: B363H-20059243
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity; Metabolic Syndrome

Keywords

Dairy; Liver fat; Glucose metabolism

Outcome Measures

Primary Outcomes (1)

• Liver fat

  Measurements of liver fat by Magnetic Resonance Imaging

  Change from Week 0 to week 16

Secondary Outcomes (11)

• Cardiometabolic risk

  Change from Week 0 to week 16

• Cardiometabolic risk

  Change from Week 0 to week 16

• Cardiometabolic risk

  Change from Week 0 to week 16

• Gut microbiome

  Change from week -4 to week 16

• Glucose metabolism (fasting samples)

  Change from Week 0 to week 16

Other Outcomes (8)

• Metabolome

  Change from week -4 to week 16

• Physical activity

  Change from week -4 to week 16

• Sleep quality

  Change from week -4 to week 16

Study Arms (4)

Regular whole milk

ACTIVE COMPARATOR

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

Dietary Supplement: Regular whole milk

Yogurt with live bacteria

EXPERIMENTAL

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

Dietary Supplement: Yogurt with live bacteria

Yogurt with inactivated bacteria

EXPERIMENTAL

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

Dietary Supplement: Yogurt with inactivated bacteria

Acidified whole milk

EXPERIMENTAL

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

Dietary Supplement: Acidified whole milk

Interventions

Regular whole milk DIETARY_SUPPLEMENT

400 g/day of regular whole milk

Also known as: Dairy product, Milk

Regular whole milk

Yogurt with live bacteria DIETARY_SUPPLEMENT

400 g/day of yogurt with live bacteria

Also known as: Fermented dairy product, Yogurt

Yogurt with live bacteria

Yogurt with inactivated bacteria DIETARY_SUPPLEMENT

400 g/day of yogurt with inactivated bacteria

Also known as: Fermented dairy product, Yogurt

Yogurt with inactivated bacteria

Acidified whole milk DIETARY_SUPPLEMENT

400 g/day of yogurt with acidified whole milk

Also known as: Dairy product

Acidified whole milk

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faidon Magkos: lead
• Arla Food for Health: collaborator
• University of Aarhus: collaborator
• Mælkeafgiftsfonden: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Frederiksberg, DK, 1958, Denmark

Location

Related Publications (1)

• Sandby K, Magkos F, Chabanova E, Petersen ET, Krarup T, Bertram HC, Kristiansen K, Geiker NRW. The effect of dairy products on liver fat and metabolic risk markers in males with abdominal obesity - a four-arm randomized controlled trial. Clin Nutr. 2024 Feb;43(2):534-542. doi: 10.1016/j.clnu.2023.12.018. Epub 2023 Dec 27.

  PMID: 38232682 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Fatty Liver

Interventions

Dairy Products; Milk; Yogurt; Cultured Milk Products

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Fermented Foods

Study Officials

• Faidon Magkos, PhD

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Until the statistical analyses are performed, principal investigator and statistician are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 16-week parallel randomized controlled trial

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: February 25, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

DK (1)