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Breakfast for Young Females (NyStart2)

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ClinicalTrials.gov Identifier: NCT04518605
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 10, 2021
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Sygekassernes Helsefond
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Overweight Adolescents Metabolic Disease Dietary Supplement: Low protein breakfast Dietary Supplement: High protein breakfast Other: Exercise training Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Breakfast for Young Females - the Importance of Breakfast Type
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low protein breakfast
Subject will eat a low protein breakfast and maintain their habitual physical activity.
 Dietary Supplement: Low protein breakfast
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.
Experimental: High protein breakfast
Subject will eat a high protein breakfast and maintain their habitual physical activity.
 Dietary Supplement: High protein breakfast
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.
Experimental: Low protein breakfast and exercise training
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)
 Dietary Supplement: Low protein breakfast
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.

Other: Exercise training
Participants will be asked to participate in organized exercise training 3 times per week.
Experimental: High protein breakfast and exercise training
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)
 Dietary Supplement: High protein breakfast
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fat mass in grams [ Time Frame: 12 weeks ]
    Measured by dual energy x-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change in Fat free mass in grams [ Time Frame: 12 weeks ]
    Measured by dual energy x-ray absorptiometry (DXA)

  2. Change in Lean body mass in grams [ Time Frame: 12 weeks ]
    Measured by dual energy x-ray absorptiometry (DXA)

  3. Change in Height (cm) [ Time Frame: 12 weeks ]
    by stadiometer

  4. Change in weight (kg) [ Time Frame: 12 weeks ]
    Tanita Scale

  5. Change in BMI (m^2/kg) [ Time Frame: 12 weeks ]
    Measured by height in meters and weight in kg

  6. Change in Waist circumference (cm) [ Time Frame: 12 weeks ]
    by tape

  7. Change in HbA1c [ Time Frame: 12 weeks ]
    by fasting blood sample

  8. Change in high density lipoprotein cholesterol (HDL cholesterol) [ Time Frame: 12 weeks ]
    by fasting blood sample

  9. Change in low density lipoprotein cholesterol (LDL cholesterol) [ Time Frame: 12 weeks ]
    by fasting blood sample

  10. Change in triacylglycerol (TG) [ Time Frame: 12 weeks ]
    by fasting blood sample

  11. Change in total cholesterol [ Time Frame: 12 weeks ]
    by fasting blood sample

  12. Change in glucose [ Time Frame: 12 weeks ]
    by fasting blood sample

  13. Change in insulin [ Time Frame: 12 weeks ]
    by fasting blood sample

  14. Change in glucose tolerance (area under the curve) [ Time Frame: 12 weeks ]
    measured by a two hour oral glucose tolerance test

  15. Change in glucose peak [ Time Frame: 12 weeks ]
    measured by a two hour oral glucose tolerance test

  16. Change in fitness (estimated VO2-max) [ Time Frame: 12 weeks ]
    Measured by Åstrand two-step bike test

  17. Change in maximal hand grip strength [ Time Frame: 12 weeks ]
    Measured by hand held dynamometer

  18. Change in maximal arm strength [ Time Frame: 12 weeks ]
    Measured by costummade dynamometer

  19. Change in maximal jump height [ Time Frame: 12 weeks ]
    Measured by squat jump with linear encoder

  20. Change in systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
    by standard blood pressure apparatus


Other Outcome Measures:
  1. Change in physical activity [ Time Frame: 12 weeks ]
    by accelerometry

  2. Changes in dietary intake [ Time Frame: 12 weeks ]
    by 4-day dietary registration

  3. Changes in calcium and supplement intake [ Time Frame: 12 weeks ]
    by a standard, validated food frequency questionnaire.

  4. Change in gut microflora [ Time Frame: 12 weeks ]
    by bacterial determination of faeces

  5. Changes in faeces pH [ Time Frame: 12 weeks ]
    by pH determination of faeces

  6. Changes in urine metabolites [ Time Frame: 12 weeks ]
    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.

  7. Changes in faeces metabolites [ Time Frame: 12 weeks ]
    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.

  8. Changes in blood metabolites [ Time Frame: 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518605


Contacts
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Contact: Mette Hansen, Assoc Prof +45 51666551 mhan@ph.au.dk

Locations
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Denmark
Aarhus University, Department for Public Health, Section for Sport Science Recruiting
Aarhus, Denmark, 8000
Contact: Mette Hansen, PhD    +4551666551    mhan@ph.au.dk   
Sponsors and Collaborators
University of Aarhus
The Danish Dairy Research Foundation, Denmark
Sygekassernes Helsefond
Investigators
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Principal Investigator: Mette Hansen, Assoc Prof University of Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04518605    
Other Study ID Numbers: NyStart2
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Dairy protein
Breakfast content
body composition
Muscle strength
 Gut microbiota/microflora
Dietary recommendations
Exercise training
Additional relevant MeSH terms:
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Metabolic Diseases
Overweight
Body Weight