Breakfast for Female Adolescent - NewStart

University of Aarhus

Status: Terminated

Conditions: Overweight Adolescents; Metabolic Disease

Treatments: Other: Skipping breakfast; Dietary Supplement: Breakfast with high protein dairy; Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04419415

ProteinLab_P9_NyStart

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

Skipping breakfast and maintain habitual physical activity

Experimental group

Description:

Subject will skip breakfast and maintain habitual physical activity.

Treatment:

Other: Skipping breakfast

High protein breakfast and maintain habitual physical activity

Experimental group

Description:

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

Treatment:

Dietary Supplement: Breakfast with high protein dairy

Other: Skipping breakfast

Skipping breakfast and exercising three times per week

Experimental group

Description:

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

Treatment:

Other: Exercise training

High protein breakfast and exercising three times per week

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Breakfast with high protein dairy

Other: Exercise training