Breakfast for Young Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breakfast for Young Women

Conditions
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Obesity, Wolman Disease, Nutrition

Intervention / Treatment
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* Other: Protein-rich breakfast
* Other: Carbohydrate-rich breakfast
* Other: No breakfast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-blind randomized crossover trail with three intervention meals.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein breakfast<br>Participants will be served a dairy-based protein-rich breakfast meal. | Other: Protein-rich breakfast<br>* 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)<br>|
| Experimental: High carbohydrate breakfast<br>Participants will be served a carbohydrate-rich breakfast meal | Other: Carbohydrate-rich breakfast<br>* 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)<br>|
| Experimental: No breakfast<br>Participants will be served no breakfast | Other: No breakfast<br>* 1 glas of water (150 ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy consumption on test days | Total energy consumption on test days (24 hour food log) | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hunger | Visual Analog Scale (10 cm) score for feeling of hunger | 0-3 hours | 
| Change in satiety | Visual Analog Scale (10 cm) score for feeling of satiety | 0-3 hours | 
| change in desire | Visual Analog Scale (10 cm) score for feeling of desire to eat | 0-3 hours | 
| Change in ghrelin | in blood sample | 0-3 hours | 
| Change in leptin | in blood sample | 0-3 hours | 
| Change in glucose-dependent insulinotropic polypeptide (GIP) | in blood sample | 0-3 hours | 
| Change in Peptide YY (PYY3-36) | in blood sample | 0-3 hours | 
| Change in insulin | in blood sample | 0-3 hours | 
| Change in glucagon | in blood sample | 0-3 hours | 
| Change in glucose | in blood sample | 0-3 hours | 
| Energy consumption the day before a test day (food registration) | Total energy consumption on the day before the test day | 0-24 hours |