Breakfast for Young Women (GoDag)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Wolman Disease; Nutrition
• Intervention / Treatment: Other: Protein-rich breakfast; Other: Carbohydrate-rich breakfast; Other: No breakfast

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height in cm	Baseline
Weight	Weight in kg	Baseline
Body composition fat	DXA-scanning to determine fat mass	Baseline
Body composition fat free	DXA-scanning to determine fat free mass	Baseline

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Danish Dairy Research Foundation, Denmark
• Investigators: Principal Investigator: Mette Hansen, Assoc Prof, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Lipidoses; Lipid Metabolism, Inborn Errors; Cholesterol Ester Storage Disease; Wolman Disease
• Other Study ID Numbers: P11-GoDag

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No