Breakfast for Young Women

Obesity Clinical Trial

— GoDag  

Official title:

Breakfast for Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652713
• Other study ID #: P11-GoDag
• Status: Completed
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: November 21, 2023

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrition
• Obesity
• Wolman Disease

Intervention

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)
• 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)
• No breakfast
1 glas of water (150 ml)

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Height in cm	Baseline
Other	Weight	Weight in kg	Baseline
Other	Body composition fat	DXA-scanning to determine fat mass	Baseline
Other	Body composition fat free	DXA-scanning to determine fat free mass	Baseline
Primary	Energy consumption on test days	Total energy consumption on test days (24 hour food log)	0-24 hours
Secondary	Change in hunger	Visual Analog Scale (10 cm) score for feeling of hunger	0-3 hours
Secondary	Change in satiety	Visual Analog Scale (10 cm) score for feeling of satiety	0-3 hours
Secondary	change in desire	Visual Analog Scale (10 cm) score for feeling of desire to eat	0-3 hours
Secondary	Change in ghrelin	in blood sample	0-3 hours
Secondary	Change in leptin	in blood sample	0-3 hours
Secondary	Change in glucose-dependent insulinotropic polypeptide (GIP)	in blood sample	0-3 hours
Secondary	Change in Peptide YY (PYY3-36)	in blood sample	0-3 hours
Secondary	Change in insulin	in blood sample	0-3 hours
Secondary	Change in glucagon	in blood sample	0-3 hours
Secondary	Change in glucose	in blood sample	0-3 hours
Secondary	Energy consumption the day before a test day (food registration)	Total energy consumption on the day before the test day	0-24 hours