NCT04518605

Brief Summary

Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 10, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 17, 2022

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

August 10, 2020

Last Update Submit

November 16, 2022

Conditions

Overweight and ObesityOverweight AdolescentsMetabolic Disease

Keywords

Dairy proteinBreakfast contentbody compositionMuscle strengthGut microbiota/microfloraDietary recommendationsExercise training

Outcome Measures

Primary Outcomes (1)

  • Change in Fat mass in grams

    Measured by dual energy x-ray absorptiometry (DXA)

    12 weeks

Secondary Outcomes (20)

  • Change in Fat free mass in grams

    12 weeks

  • Change in Lean body mass in grams

    12 weeks

  • Change in Height (cm)

    12 weeks

  • Change in weight (kg)

    12 weeks

  • Change in BMI (m^2/kg)

    12 weeks

  • +15 more secondary outcomes

Other Outcomes (8)

  • Change in physical activity

    12 weeks

  • Changes in dietary intake

    12 weeks

  • Changes in calcium and supplement intake

    12 weeks

  • +5 more other outcomes

Study Arms (4)

Low protein breakfast

EXPERIMENTAL

Subject will eat a low protein breakfast and maintain their habitual physical activity.

Dietary Supplement: Low protein breakfast

High protein breakfast

EXPERIMENTAL

Subject will eat a high protein breakfast and maintain their habitual physical activity.

Dietary Supplement: High protein breakfast

Low protein breakfast and exercise training

EXPERIMENTAL

Subject will consume a low protein breakfast (bread, jam, juice) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)

Dietary Supplement: Low protein breakfastOther: Exercise training

High protein breakfast and exercise training

EXPERIMENTAL

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

Dietary Supplement: High protein breakfastOther: Exercise training

Interventions

Low protein breakfastDIETARY_SUPPLEMENT

Low protein yoghurt 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.

Low protein breakfastLow protein breakfast and exercise training
High protein breakfastDIETARY_SUPPLEMENT

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.

High protein breakfastHigh protein breakfast and exercise training
Exercise trainingOTHER

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

High protein breakfast and exercise trainingLow protein breakfast and exercise training

Eligibility Criteria

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

You may qualify if:

  • Body mass index \> 25
  • Regular exercise \< 1 hour per week

You may not qualify if:

  • 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

Related Publications (1)

  • Dalgaard LB, Thams L, Skovgaard Jensen J, Jorgensen AA, Breenfeldt Andersen A, Gejl KD, Bertram HC, Hansen M. No effects of high- v. low-protein breakfast on body composition and cardiometabolic health in young women with overweight: the NewStart randomised trial. Br J Nutr. 2025 Jan 14;133(1):126-135. doi: 10.1017/S0007114524003015. Epub 2024 Nov 26.

    PMID: 39587799DERIVED

MeSH Terms

Conditions

OverweightObesityMetabolic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mette Hansen, Assoc Prof

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 19, 2020

Study Start

August 15, 2020

Primary Completion

December 15, 2021

Study Completion

March 1, 2022

Last Updated

November 17, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)