Breakfast for Young Women

NCT04652713 | Completed DMC

• 1 other identifier: P11-GoDag
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Wolman Disease; Nutrition

Outcome Measures

Primary Outcomes (1)

• Energy consumption on test days

  Total energy consumption on test days (24 hour food log)

  0-24 hours

Secondary Outcomes (11)

• Change in hunger

  0-3 hours

• Change in satiety

  0-3 hours

• change in desire

  0-3 hours

• Change in ghrelin

  0-3 hours

• Change in leptin

  0-3 hours

Other Outcomes (4)

• Height

  Baseline

• Weight

  Baseline

• Body composition fat

  Baseline

Study Arms (3)

High protein breakfast

EXPERIMENTAL

Participants will be served a dairy-based protein-rich breakfast meal.

Other: Protein-rich breakfast

High carbohydrate breakfast

EXPERIMENTAL

Participants will be served a carbohydrate-rich breakfast meal

Other: Carbohydrate-rich breakfast

No breakfast

EXPERIMENTAL

Participants will be served no breakfast

Other: No breakfast

Interventions

Protein-rich breakfast OTHER

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)

High protein breakfast

Carbohydrate-rich breakfast OTHER

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)

High carbohydrate breakfast

No breakfast OTHER

1 glas of water (150 ml)

No breakfast

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index \> 25
• Age 18-25 years
• Regular exercise \< 5 hour per week

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Dairy Research Foundation, Denmark: collaborator

Study Sites (1)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Obesity; Wolman Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholesterol Ester Storage Disease; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Infant, Newborn, Diseases; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Mette Hansen, Assoc Prof

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized crossover trail with three intervention meals.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: November 24, 2020
• Primary Completion: September 1, 2022
• Study Completion: November 21, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)