Breakfast for Young Women

Not Applicable

Completed

• Conditions: Wolman Disease; Nutrition; Obesity
• Interventions: Other: Protein-rich breakfast; Other: No breakfast; Other: Carbohydrate-rich breakfast

• Registration Number: NCT04652713
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2020-11-24
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Primary Completion: 2022-09-01
• Study Completion: 2023-11-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High protein breakfast	Protein-rich breakfast	Participants will be served a dairy-based protein-rich breakfast meal.
No breakfast	No breakfast	Participants will be served no breakfast
High carbohydrate breakfast	Carbohydrate-rich breakfast	Participants will be served a carbohydrate-rich breakfast meal

Primary Outcome Measures

Name	Time	Method
Energy consumption on test days	0-24 hours	Total energy consumption on test days (24 hour food log)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University, Department for Public Health, Section for Sport Science; 🇩🇰 Aarhus, Denmark