Breakfast for Female Adolescent - NewStart

Metabolic Disease Clinical Trial

— NewStart  

Official title:

Breakfast for Female Adolescent - NewStart

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04419415
• Other study ID #: ProteinLab_P9_NyStart
• Status: Terminated
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Overweight
• Overweight Adolescents

Intervention

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.

Other:
• Exercise training
Participants will be asked to participate in organized exercise training 3 times per week.
• Skipping breakfast
Participants will be asked to skip breakfast.

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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