Breakfast for Female Adolescent - NewStart

N/ATerminatedNCT04419415

University of Aarhus25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Overweight Adolescents Metabolic Disease

Interventions

Breakfast with high protein dairyDIETARY_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 trainingOTHER

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

Skipping breakfastOTHER

Participants will be asked to skip breakfast.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Aarhus, Denmark

Outcomes

Primary Outcomes

Body composition (DXA scan) 1

Fat mass in grams

Time frame: 12 weeks

Body composition (DXA scan) 2

Fat free mass in grams

Time frame: 12 weeks

Secondary Outcomes

HbA1c

Blood sample measurement of HbA1c

Time frame: 12 weeks

LDL

Blood sample measurement of LDL

Time frame: 12 weeks

HDL

Blood sample measurement of HDL

Time frame: 12 weeks

Health related blood parameter 1

blood sample measurement of fasting glucose

Time frame: 12 weeks

Health related blood parameter 2

Blood sample measurement of fasting insulin

Time frame: 12 weeks

Health related parameter

Oral glucose tolerance test measured as the area under the curve

Time frame: 12 weeks

Fitness

Aastrand bike test

Time frame: 12 weeks

Muscle strength

grib strength (kg)

Data from ClinicalTrials.gov

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