Breakfast for Young Women (GoDag)
Primary Purpose
Obesity, Wolman Disease, Nutrition
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Protein-rich breakfast
Carbohydrate-rich breakfast
No breakfast
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility 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
Sites / Locations
- Aarhus University, Department for Public Health, Section for Sport ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
High protein breakfast
High carbohydrate breakfast
No breakfast
Arm Description
Participants will be served a dairy-based protein-rich breakfast meal.
Participants will be served a carbohydrate-rich breakfast meal
Participants will be served no breakfast
Outcomes
Primary Outcome Measures
Energy consumption on test days
Total energy consumption on test days (24 hour food log)
Secondary Outcome Measures
Change in hunger
Visual Analog Scale (10 cm) score for feeling of hunger
Change in satiety
Visual Analog Scale (10 cm) score for feeling of satiety
change in desire
Visual Analog Scale (10 cm) score for feeling of desire to eat
Change in ghrelin
in blood sample
Change in leptin
in blood sample
Change in glucose-dependent insulinotropic polypeptide (GIP)
in blood sample
Change in Peptide YY (PYY3-36)
in blood sample
Change in insulin
in blood sample
Change in glucagon
in blood sample
Change in glucose
in blood sample
Energy consumption the day before a test day (food registration)
Total energy consumption on the day before the test day
Full Information
NCT ID
NCT04652713
First Posted
November 26, 2020
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
The Danish Dairy Research Foundation, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04652713
Brief Title
Breakfast for Young Women
Acronym
GoDag
Official Title
Breakfast for Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Dairy Research Foundation, Denmark
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Wolman Disease, Nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-blind randomized crossover trail with three intervention meals.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High protein breakfast
Arm Type
Experimental
Arm Description
Participants will be served a dairy-based protein-rich breakfast meal.
Arm Title
High carbohydrate breakfast
Arm Type
Experimental
Arm Description
Participants will be served a carbohydrate-rich breakfast meal
Arm Title
No breakfast
Arm Type
Experimental
Arm Description
Participants will be served no breakfast
Intervention Type
Other
Intervention Name(s)
Protein-rich 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.
1 glas of water (150 ml)
Intervention Type
Other
Intervention Name(s)
Carbohydrate-rich breakfast
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
No breakfast
Intervention Description
1 glas of water (150 ml)
Primary Outcome Measure Information:
Title
Energy consumption on test days
Description
Total energy consumption on test days (24 hour food log)
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Change in hunger
Description
Visual Analog Scale (10 cm) score for feeling of hunger
Time Frame
0-3 hours
Title
Change in satiety
Description
Visual Analog Scale (10 cm) score for feeling of satiety
Time Frame
0-3 hours
Title
change in desire
Description
Visual Analog Scale (10 cm) score for feeling of desire to eat
Time Frame
0-3 hours
Title
Change in ghrelin
Description
in blood sample
Time Frame
0-3 hours
Title
Change in leptin
Description
in blood sample
Time Frame
0-3 hours
Title
Change in glucose-dependent insulinotropic polypeptide (GIP)
Description
in blood sample
Time Frame
0-3 hours
Title
Change in Peptide YY (PYY3-36)
Description
in blood sample
Time Frame
0-3 hours
Title
Change in insulin
Description
in blood sample
Time Frame
0-3 hours
Title
Change in glucagon
Description
in blood sample
Time Frame
0-3 hours
Title
Change in glucose
Description
in blood sample
Time Frame
0-3 hours
Title
Energy consumption the day before a test day (food registration)
Description
Total energy consumption on the day before the test day
Time Frame
0-24 hours
Other Pre-specified Outcome Measures:
Title
Height
Description
Height in cm
Time Frame
Baseline
Title
Weight
Description
Weight in kg
Time Frame
Baseline
Title
Body composition fat
Description
DXA-scanning to determine fat mass
Time Frame
Baseline
Title
Body composition fat free
Description
DXA-scanning to determine fat free mass
Time Frame
Baseline
10. Eligibility
Sex
Female
Gender Based
Yes
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Hansen, PhD
Phone
+45 51666551
Email
mhan@ph.au.dk
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Hansen, PhD
Phone
+4551666551
Email
mhan@ph.au.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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