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Breakfast for Young Females (NyStart2)

Primary Purpose

Overweight and Obesity, Overweight Adolescents, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low protein breakfast
High protein breakfast
Exercise training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index > 25
  • Regular exercise < 1 hour per week

Exclusion Criteria:

  • 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

Low protein breakfast

High protein breakfast

Low protein breakfast and exercise training

High protein breakfast and exercise training

Arm Description

Subject will eat a low protein breakfast and maintain their habitual physical activity.

Subject will eat a high protein breakfast and maintain their habitual physical activity.

Subject will consume a low protein breakfast (bread, jam, juice) and 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) with oats) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Outcomes

Primary Outcome Measures

Change in Fat mass in grams
Measured by dual energy x-ray absorptiometry (DXA)

Secondary Outcome Measures

Change in Fat free mass in grams
Measured by dual energy x-ray absorptiometry (DXA)
Change in Lean body mass in grams
Measured by dual energy x-ray absorptiometry (DXA)
Change in Height (cm)
by stadiometer
Change in weight (kg)
Tanita Scale
Change in BMI (m^2/kg)
Measured by height in meters and weight in kg
Change in Waist circumference (cm)
by tape
Change in HbA1c
by fasting blood sample
Change in high density lipoprotein cholesterol (HDL cholesterol)
by fasting blood sample
Change in low density lipoprotein cholesterol (LDL cholesterol)
by fasting blood sample
Change in triacylglycerol (TG)
by fasting blood sample
Change in total cholesterol
by fasting blood sample
Change in glucose
by fasting blood sample
Change in insulin
by fasting blood sample
Change in glucose tolerance (area under the curve)
measured by a two hour oral glucose tolerance test
Change in glucose peak
measured by a two hour oral glucose tolerance test
Change in fitness (estimated VO2-max)
Measured by Åstrand two-step bike test
Change in maximal hand grip strength
Measured by hand held dynamometer
Change in maximal arm strength
Measured by costummade dynamometer
Change in maximal jump height
Measured by squat jump with linear encoder
Change in systolic and diastolic blood pressure
by standard blood pressure apparatus

Full Information

First Posted
August 10, 2020
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
The Danish Dairy Research Foundation, Denmark, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT04518605
Brief Title
Breakfast for Young Females
Acronym
NyStart2
Official Title
Breakfast for Young Females - the Importance of Breakfast Type
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

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

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 health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.
Detailed Description
The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period. The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Overweight Adolescents, Metabolic Disease
Keywords
Dairy protein, Breakfast content, body composition, Muscle strength, Gut microbiota/microflora, Dietary recommendations, Exercise training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low protein breakfast
Arm Type
Experimental
Arm Description
Subject will eat a low protein breakfast and maintain their habitual physical activity.
Arm Title
High protein breakfast
Arm Type
Experimental
Arm Description
Subject will eat a high protein breakfast and maintain their habitual physical activity.
Arm Title
Low protein breakfast and exercise training
Arm Type
Experimental
Arm Description
Subject will consume a low protein breakfast (bread, jam, juice) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)
Arm Title
High protein breakfast and exercise training
Arm Type
Experimental
Arm Description
Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr) with oats) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)
Intervention Type
Dietary Supplement
Intervention Name(s)
Low protein breakfast
Intervention Description
Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume ~60 g bread, 20 g jam and 250 ml juice for breakfast.
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein breakfast
Intervention Description
High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats 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.
Primary Outcome Measure Information:
Title
Change in Fat mass in grams
Description
Measured by dual energy x-ray absorptiometry (DXA)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Fat free mass in grams
Description
Measured by dual energy x-ray absorptiometry (DXA)
Time Frame
12 weeks
Title
Change in Lean body mass in grams
Description
Measured by dual energy x-ray absorptiometry (DXA)
Time Frame
12 weeks
Title
Change in Height (cm)
Description
by stadiometer
Time Frame
12 weeks
Title
Change in weight (kg)
Description
Tanita Scale
Time Frame
12 weeks
Title
Change in BMI (m^2/kg)
Description
Measured by height in meters and weight in kg
Time Frame
12 weeks
Title
Change in Waist circumference (cm)
Description
by tape
Time Frame
12 weeks
Title
Change in HbA1c
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in high density lipoprotein cholesterol (HDL cholesterol)
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in low density lipoprotein cholesterol (LDL cholesterol)
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in triacylglycerol (TG)
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in total cholesterol
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in glucose
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in insulin
Description
by fasting blood sample
Time Frame
12 weeks
Title
Change in glucose tolerance (area under the curve)
Description
measured by a two hour oral glucose tolerance test
Time Frame
12 weeks
Title
Change in glucose peak
Description
measured by a two hour oral glucose tolerance test
Time Frame
12 weeks
Title
Change in fitness (estimated VO2-max)
Description
Measured by Åstrand two-step bike test
Time Frame
12 weeks
Title
Change in maximal hand grip strength
Description
Measured by hand held dynamometer
Time Frame
12 weeks
Title
Change in maximal arm strength
Description
Measured by costummade dynamometer
Time Frame
12 weeks
Title
Change in maximal jump height
Description
Measured by squat jump with linear encoder
Time Frame
12 weeks
Title
Change in systolic and diastolic blood pressure
Description
by standard blood pressure apparatus
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in physical activity
Description
by accelerometry
Time Frame
12 weeks
Title
Changes in dietary intake
Description
by 4-day dietary registration
Time Frame
12 weeks
Title
Changes in calcium and supplement intake
Description
by a standard, validated food frequency questionnaire.
Time Frame
12 weeks
Title
Change in gut microflora
Description
by bacterial determination of faeces
Time Frame
12 weeks
Title
Changes in faeces pH
Description
by pH determination of faeces
Time Frame
12 weeks
Title
Changes in urine metabolites
Description
To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine samples will be collected to perform a metabolomics analysis by mass spectroscopy.
Time Frame
12 weeks
Title
Changes in faeces metabolites
Description
To evaluate the effect of the intervention on the metabolism through a metabolomic approach. Faeces samples will be collected to perform a metabolomics analysis by mass spectroscopy.
Time Frame
12 weeks
Title
Changes in blood metabolites
Description
To evaluate the effect of the intervention on metabolism through a metabolomic approach. Blood samples will be collected to perform a metabolomics analysis by mass spectroscopy.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index > 25 Regular exercise < 1 hour per week Exclusion Criteria: 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, Assoc Prof
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 Young Females

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