Breakfast for Young Females

NCT ID: NCT04518605

Last Updated: 2022-11-17

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

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2022-03-01

Brief Summary

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Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.

Detailed Description

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The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period.

The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.

Conditions

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Overweight and Obesity Overweight Adolescents Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low protein breakfast

Subject will eat a low protein breakfast and maintain their habitual physical activity.

Group Type EXPERIMENTAL

Low protein breakfast

Intervention Type DIETARY_SUPPLEMENT

Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume \~60 g bread, 20 g jam and 250 ml juice for breakfast.

High protein breakfast

Subject will eat a high protein breakfast and maintain their habitual physical activity.

Group Type EXPERIMENTAL

High protein breakfast

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) yoghurt with 40 g oats for breakfast.

Low protein breakfast and exercise training

Subject will consume a low protein breakfast (bread, jam, juice) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Group Type EXPERIMENTAL

Low protein breakfast

Intervention Type DIETARY_SUPPLEMENT

Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume \~60 g bread, 20 g jam and 250 ml juice for breakfast.

Exercise training

Intervention Type OTHER

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

High protein breakfast and exercise training

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

Group Type EXPERIMENTAL

High protein breakfast

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) yoghurt with 40 g oats 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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Low protein breakfast

Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume \~60 g bread, 20 g jam and 250 ml juice for breakfast.

Intervention Type DIETARY_SUPPLEMENT

High protein breakfast

High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats 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

Eligibility Criteria

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Inclusion Criteria

* Body mass index \> 25
* Regular exercise \< 1 hour per week

Exclusion Criteria

* 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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Dairy Research Foundation, Denmark

OTHER

Sponsor Role collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mette Hansen, Assoc Prof

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

References

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Dalgaard LB, Thams L, Skovgaard Jensen J, Jorgensen AA, Breenfeldt Andersen A, Gejl KD, Bertram HC, Hansen M. No effects of high- v. low-protein breakfast on body composition and cardiometabolic health in young women with overweight: the NewStart randomised trial. Br J Nutr. 2025 Jan 14;133(1):126-135. doi: 10.1017/S0007114524003015. Epub 2024 Nov 26.

Reference Type DERIVED
PMID: 39587799 (View on PubMed)

Other Identifiers

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NyStart2

Identifier Type: -

Identifier Source: org_study_id

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