Breakfast for Female Adolescent - NewStart (NewStart)

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.

Study Overview

• Status: Terminated
• Conditions: Overweight Adolescents; Metabolic Disease
• Intervention / Treatment: Other: Exercise training; Other: Skipping breakfast; Dietary supplement: Breakfast with high protein dairy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skipping breakfast and maintain habitual physical activity; Subject will skip breakfast and maintain habitual physical activity.	Other: Skipping breakfast; Participants will be asked to skip breakfast.
Experimental: 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.	Other: Skipping breakfast; Participants will be asked to skip breakfast.; Dietary supplement: 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.
Experimental: 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)	Other: Exercise training; Participants will be asked to participate in organized exercise training 3 times per week.
Experimental: 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)	Other: Exercise training; Participants will be asked to participate in organized exercise training 3 times per week.; Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition (DXA scan) 1	Fat mass in grams	12 weeks
Body composition (DXA scan) 2	Fat free mass in grams	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Blood sample measurement of HbA1c	12 weeks
LDL	Blood sample measurement of LDL	12 weeks
HDL	Blood sample measurement of HDL	12 weeks
Health related blood parameter 1	blood sample measurement of fasting glucose	12 weeks
Health related blood parameter 2	Blood sample measurement of fasting insulin	12 weeks
Health related parameter	Oral glucose tolerance test measured as the area under the curve	12 weeks
Fitness	Aastrand bike test	12 weeks
Muscle strength	grib strength (kg)	12 weeks
maximal jump height	maximal jump height (cm)	12 weeks
weight	Body weight (kg)	12 weeks
Height	Body hight (m)	12 weeks
BMI	weight measurement in kg, height in meters	12 weeks
Food log	4-day food log (energy in KJ)	12 weeks
Gut microflora	by bacterial determination of faeces	12 weeks
Feaces pH	by pH determination of faeces	12 weeks
Urine metabolites	by metabolomics	12 weeks
Blood metabolites	by metabolomics	12 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Danish Dairy Research Foundation, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Metabolic Diseases
• Other Study ID Numbers: ProteinLab_P9_NyStart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No