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Breakfast for Female Adolescent - NewStart (NewStart)

Primary Purpose

Overweight Adolescents, Metabolic Disease

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Breakfast with high protein dairy
Exercise training
Skipping breakfast
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight Adolescents

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Skipping breakfast and maintain habitual physical activity

High protein breakfast and maintain habitual physical activity

Skipping breakfast and exercising three times per week

High protein breakfast and exercising three times per week

Arm Description

Subject will skip 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.

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

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)

Outcomes

Primary Outcome Measures

Body composition (DXA scan) 1
Fat mass in grams
Body composition (DXA scan) 2
Fat free mass in grams

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2020
Last Updated
April 28, 2021
Sponsor
University of Aarhus
Collaborators
The Danish Dairy Research Foundation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04419415
Brief Title
Breakfast for Female Adolescent - NewStart
Acronym
NewStart
Official Title
Breakfast for Female Adolescent - NewStart
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
covid-19 lock down
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Dairy Research Foundation, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight Adolescents, Metabolic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skipping breakfast and maintain habitual physical activity
Arm Type
Experimental
Arm Description
Subject will skip breakfast and maintain habitual physical activity.
Arm Title
High protein breakfast and maintain habitual physical activity
Arm Type
Experimental
Arm Description
Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity.
Arm Title
Skipping breakfast and exercising three times per week
Arm Type
Experimental
Arm Description
Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity)
Arm Title
High protein breakfast and exercising three times per week
Arm Type
Experimental
Arm 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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Breakfast with high protein dairy
Intervention Description
High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Participants will be asked to participate in organized exercise training 3 times per week.
Intervention Type
Other
Intervention Name(s)
Skipping breakfast
Intervention Description
Participants will be asked to skip breakfast.
Primary Outcome Measure Information:
Title
Body composition (DXA scan) 1
Description
Fat mass in grams
Time Frame
12 weeks
Title
Body composition (DXA scan) 2
Description
Fat free mass in grams
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Blood sample measurement of HbA1c
Time Frame
12 weeks
Title
LDL
Description
Blood sample measurement of LDL
Time Frame
12 weeks
Title
HDL
Description
Blood sample measurement of HDL
Time Frame
12 weeks
Title
Health related blood parameter 1
Description
blood sample measurement of fasting glucose
Time Frame
12 weeks
Title
Health related blood parameter 2
Description
Blood sample measurement of fasting insulin
Time Frame
12 weeks
Title
Health related parameter
Description
Oral glucose tolerance test measured as the area under the curve
Time Frame
12 weeks
Title
Fitness
Description
Aastrand bike test
Time Frame
12 weeks
Title
Muscle strength
Description
grib strength (kg)
Time Frame
12 weeks
Title
maximal jump height
Description
maximal jump height (cm)
Time Frame
12 weeks
Title
weight
Description
Body weight (kg)
Time Frame
12 weeks
Title
Height
Description
Body hight (m)
Time Frame
12 weeks
Title
BMI
Description
weight measurement in kg, height in meters
Time Frame
12 weeks
Title
Food log
Description
4-day food log (energy in KJ)
Time Frame
12 weeks
Title
Gut microflora
Description
by bacterial determination of faeces
Time Frame
12 weeks
Title
Feaces pH
Description
by pH determination of faeces
Time Frame
12 weeks
Title
Urine metabolites
Description
by metabolomics
Time Frame
12 weeks
Title
Blood metabolites
Description
by metabolomics
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Hansen, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, Department for Public Health, Section for Sport Science
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Breakfast for Female Adolescent - NewStart

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