Breakfast for Female Adolescent - NewStart

NCT ID: NCT04419415

Last Updated: 2021-05-03

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

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2020-06-01

Brief Summary

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Investigators will test the long-term health effects of eating a dairy-based protein-rich breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast skipping' young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces (microbiota activity and composition), satiety and daily energy intake will be collected.

Detailed Description

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The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to skip breakfast or eat high-protein yoghurt products (300g/day) and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention period.

The primary outcome will be fat mass and fat free mass. The investigators will also measure effects on weigth, waiste, health-related blood paramenters, muscle function, metabolites in urine and blood, and gut microflora and pH.

Conditions

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Overweight Adolescents Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Skipping breakfast and maintain habitual physical activity

Subject will skip breakfast and maintain habitual physical activity.

Group Type EXPERIMENTAL

Skipping breakfast

Intervention Type OTHER

Participants will be asked to skip breakfast.

High protein breakfast and maintain habitual physical activity

Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity.

Group Type EXPERIMENTAL

Breakfast with high protein dairy

Intervention Type DIETARY_SUPPLEMENT

High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.

Skipping breakfast

Intervention Type OTHER

Participants will be asked to skip breakfast.

Skipping breakfast and exercising three times per week

Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

Participants will be asked to participate in organized exercise training 3 times per week.

High protein breakfast and exercising three times per week

Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Group Type EXPERIMENTAL

Breakfast with high protein dairy

Intervention Type DIETARY_SUPPLEMENT

High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.

Exercise training

Intervention Type OTHER

Participants will be asked to participate in organized exercise training 3 times per week.

Interventions

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Breakfast with high protein dairy

High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.

Intervention Type DIETARY_SUPPLEMENT

Exercise training

Participants will be asked to participate in organized exercise training 3 times per week.

Intervention Type OTHER

Skipping breakfast

Participants will be asked to skip breakfast.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \>25
* exercising \< 1 h per week.

Exclusion Criteria

* smoking
* illness and use of medication affecting the study outcomes
* allergy towards milk and yoghurt
* weightloss/gain \>5kg the last 6 months
* dieting
* eating disorder
* pregnancy
* breast feeding
* unable to speak and understand danish
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Dairy Research Foundation, Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Mette Hansen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ProteinLab_P9_NyStart

Identifier Type: -

Identifier Source: org_study_id

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