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Completed

NCT Number: NCT04518605

Breakfast for Young Females

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.

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Key information

Conditions

Overweight and Obesity Body Weight Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight Adolescents Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low protein breakfast

Dietary Supplement

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.

High protein breakfast

Dietary Supplement

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.

Exercise training

Other

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

Primary outcomes

  1. Change in Fat mass in grams

    Time frame: 12 weeks

    Measured by dual energy x-ray absorptiometry (DXA)

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Sygekassernes Helsefond
  • The Danish Dairy Research Foundation, Denmark

Registry information

Official study title

Breakfast for Young Females - the Importance of Breakfast Type

Acronym: NyStart2

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2020
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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