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Completed

NCT Number: NCT04652713

Breakfast for Young Women

Investigators will in a crossover study test the health effects of eating a dairy-based protein-rich breakfast, isocaloric carbohydrate-rich breakfast or no breakfast in young overweight women. Determination of satiety and hunger using visual analog scores (VAS), collection of blood samples and 2x 24 hours food logs will be collected.

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Key information

Conditions

Obesity Body Weight Cholesterol Ester Storage Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Infant, Newborn, Diseases Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Nutrition Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Wolman Disease

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, 8000, Denmark

About this study

This study is a single-blind randomized Cross-Over trial with 30 women aged 18-30 years, each completing three trials. Participants will consume either dairy-based protein-rich breakfast, isocaloric, fiber matched, fat matched, carbohydrate-rich breakfast or no breakfast in randomized order. Three hours later a standardized ad libitum lunch will be served.

Blood samples will be collected (pre, 10 min, 30 min, 60 min, 120 min, 175 min after breakfast) and VAS rating hunger, satiety and desire to eat will be determined (pre, during breakfast, 10, 30, 60, 90, 120, 180 min, during lunch, after lunch). Twenty-four hour food logs on the day before the test day and on the test day will be collected.

Participants will be characterized by determining height (cm), weight (kg), and body composition by a dual-energy X-ray (DXA) scan before the first test day.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index > 25
  • Age 18-25 years
  • Regular exercise < 5 hour per week

Exclusion criteria

  • illness and use of medication affecting the study outcomes
  • allergy towards lactose or gluten
  • weightloss/gain >5kg the last 6 months
  • dieting
  • eating disorder
  • pregnancy
  • breast feeding
  • unable to speak and understand danish

Treatment and study plan

Protein-rich breakfast

Other

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.

1 glas of water (150 ml)

Carbohydrate-rich breakfast

Other

Low protein breakfast 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.

1 glas of water (150 ml)

No Breakfast

Other

1 glas of water (150 ml)

Primary outcomes

  1. Energy consumption on test days

    Time frame: 0-24 hours

    Total energy consumption on test days (24 hour food log)

Secondary outcomes

  1. Change in hunger

    Time frame: 0-3 hours

    Visual Analog Scale (10 cm) score for feeling of hunger

  2. Change in satiety

    Time frame: 0-3 hours

    Visual Analog Scale (10 cm) score for feeling of satiety

  3. change in desire

    Time frame: 0-3 hours

    Visual Analog Scale (10 cm) score for feeling of desire to eat

  4. Change in ghrelin

    Time frame: 0-3 hours

    in blood sample

  5. Change in leptin

    Time frame: 0-3 hours

    in blood sample

  6. Change in glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: 0-3 hours

    in blood sample

  7. Change in Peptide YY (PYY3-36)

    Time frame: 0-3 hours

    in blood sample

  8. Change in insulin

    Time frame: 0-3 hours

    in blood sample

  9. Change in glucagon

    Time frame: 0-3 hours

    in blood sample

  10. Change in glucose

    Time frame: 0-3 hours

    in blood sample

  11. Energy consumption the day before a test day (food registration)

    Time frame: 0-24 hours

    Total energy consumption on the day before the test day

Other outcomes

  1. Height

    Time frame: Baseline

    Height in cm

  2. Weight

    Time frame: Baseline

    Weight in kg

  3. Body composition fat

    Time frame: Baseline

    DXA-scanning to determine fat mass

  4. Body composition fat free

    Time frame: Baseline

    DXA-scanning to determine fat free mass

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish Dairy Research Foundation, Denmark

Registry information

Acronym: GoDag

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 3, 2020
Registry last updated
May 9, 2024

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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