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Breakfast for Young Women (GoDag)

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ClinicalTrials.gov Identifier: NCT04652713
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Wolman Disease Nutrition Other: Protein-rich breakfast Other: Carbohydrate-rich breakfast Other: No breakfast Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-blind randomized crossover trail with three intervention meals.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Breakfast for Young Women
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High protein breakfast
Participants will be served a dairy-based protein-rich breakfast meal.
 Other: Protein-rich 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.

1 glas of water (150 ml)
Experimental: High carbohydrate breakfast
Participants will be served a carbohydrate-rich breakfast meal
 Other: Carbohydrate-rich breakfast

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)
Experimental: No breakfast
Participants will be served no breakfast
 Other: No breakfast
1 glas of water (150 ml)


Outcome Measures
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Primary Outcome Measures :
  1. Energy consumption on test days [ Time Frame: 0-24 hours ]
    Total energy consumption on test days (24 hour food log)


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT04652713


Contacts
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Contact: Mette Hansen, PhD +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
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: NCT04652713    
Other Study ID Numbers: P11-GoDag
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: November 2020
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
Additional relevant MeSH terms:
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Wolman Disease
Cholesterol Ester Storage Disease
Lipidoses
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Lysosomal Storage Diseases
Infant, Newborn, Diseases
Lipid Metabolism Disorders
Metabolic Diseases