NCT04419415

Brief Summary

Investigators will test the long-term health effects of eating a dairy-based protein-rich breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast skipping' young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces (microbiota activity and composition), satiety and daily energy intake will be collected.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

March 13, 2020

Last Update Submit

April 28, 2021

Conditions

Overweight AdolescentsMetabolic Disease

Outcome Measures

Primary Outcomes (2)

  • Body composition (DXA scan) 1

    Fat mass in grams

    12 weeks

  • Body composition (DXA scan) 2

    Fat free mass in grams

    12 weeks

Secondary Outcomes (17)

  • HbA1c

    12 weeks

  • LDL

    12 weeks

  • HDL

    12 weeks

  • Health related blood parameter 1

    12 weeks

  • Health related blood parameter 2

    12 weeks

  • +12 more secondary outcomes

Study Arms (4)

Skipping breakfast and maintain habitual physical activity

EXPERIMENTAL

Subject will skip breakfast and maintain habitual physical activity.

Other: Skipping breakfast

High protein breakfast and maintain habitual physical activity

EXPERIMENTAL

Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity.

Dietary Supplement: Breakfast with high protein dairyOther: Skipping breakfast

Skipping breakfast and exercising three times per week

EXPERIMENTAL

Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Other: Exercise training

High protein breakfast and exercising three times per week

EXPERIMENTAL

Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Dietary Supplement: Breakfast with high protein dairyOther: Exercise training

Interventions

Breakfast with high protein dairyDIETARY_SUPPLEMENT

High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.

High protein breakfast and exercising three times per weekHigh protein breakfast and maintain habitual physical activity
Exercise trainingOTHER

Participants will be asked to participate in organized exercise training 3 times per week.

High protein breakfast and exercising three times per weekSkipping breakfast and exercising three times per week
Skipping breakfastOTHER

Participants will be asked to skip breakfast.

High protein breakfast and maintain habitual physical activitySkipping breakfast and maintain habitual physical activity

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>25
  • exercising \< 1 h per week.

You may not qualify if:

  • smoking
  • illness and use of medication affecting the study outcomes
  • allergy towards milk and yoghurt
  • weightloss/gain \>5kg the last 6 months
  • dieting
  • eating disorder
  • pregnancy
  • breast feeding
  • unable to speak and understand danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

BreakfastExercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mette Hansen, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2x2 design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 13, 2020

First Posted

June 5, 2020

Study Start

December 15, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)