Fermented Dairy Products and The Metabolic Syndrome

NCT ID: NCT04755530

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight or Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

16-week parallel randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Until the statistical analyses are performed, principal investigator and statistician are blinded

Study Groups

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Regular whole milk

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

Group Type ACTIVE_COMPARATOR

Regular whole milk

Intervention Type DIETARY_SUPPLEMENT

400 g/day of regular whole milk

Yogurt with live bacteria

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

Group Type EXPERIMENTAL

Yogurt with live bacteria

Intervention Type DIETARY_SUPPLEMENT

400 g/day of yogurt with live bacteria

Yogurt with inactivated bacteria

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

Group Type EXPERIMENTAL

Yogurt with inactivated bacteria

Intervention Type DIETARY_SUPPLEMENT

400 g/day of yogurt with inactivated bacteria

Acidified whole milk

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

Group Type EXPERIMENTAL

Acidified whole milk

Intervention Type DIETARY_SUPPLEMENT

400 g/day of yogurt with acidified whole milk

Interventions

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Regular whole milk

400 g/day of regular whole milk

Intervention Type DIETARY_SUPPLEMENT

Yogurt with live bacteria

400 g/day of yogurt with live bacteria

Intervention Type DIETARY_SUPPLEMENT

Yogurt with inactivated bacteria

400 g/day of yogurt with inactivated bacteria

Intervention Type DIETARY_SUPPLEMENT

Acidified whole milk

400 g/day of yogurt with acidified whole milk

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dairy product Milk Fermented dairy product Yogurt Fermented dairy product Yogurt Dairy product

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Food for Health

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Mælkeafgiftsfonden

UNKNOWN

Sponsor Role collaborator

University of Copenhagen, Department of Biology

UNKNOWN

Sponsor Role collaborator

Faidon Magkos

OTHER

Sponsor Role lead

Responsible Party

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Faidon Magkos

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Faidon Magkos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Department of Nutrition, Exercise and Sports

Locations

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University of Copenhagen, Department of Nutrition, Exercise and Sports

Frederiksberg, DK, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38232682 (View on PubMed)

Other Identifiers

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H-20059243

Identifier Type: REGISTRY

Identifier Source: secondary_id

B363

Identifier Type: -

Identifier Source: org_study_id

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