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Breakfast for Young Women (GoDag)

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University of Aarhus

Status

Completed

Conditions

Nutrition
Obesity
Wolman Disease

Treatments

Other: Protein-rich breakfast
Other: Carbohydrate-rich breakfast
Other: No breakfast

Study type

Interventional

Funder types

Other

Identifiers

NCT04652713
P11-GoDag

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 3 patient groups

High protein breakfast
Experimental group
Description:
Participants will be served a dairy-based protein-rich breakfast meal.
Treatment:
Other: Protein-rich breakfast
High carbohydrate breakfast
Experimental group
Description:
Participants will be served a carbohydrate-rich breakfast meal
Treatment:
Other: Carbohydrate-rich breakfast
No breakfast
Experimental group
Description:
Participants will be served no breakfast
Treatment:
Other: No breakfast

Trial contacts and locations

1

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Central trial contact

Mette Hansen, PhD

Data sourced from clinicaltrials.gov

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