Breakfast for Young Females (NyStart2)

Breakfast for Young Females - the Importance of Breakfast Type

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Overweight Adolescents; Metabolic Disease
• Intervention / Treatment: Dietary supplement: Low protein breakfast; Dietary supplement: High protein breakfast; Other: Exercise training

Detailed Description

The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period.

The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.

• Study Type: Interventional
• Enrollment (Actual): 61
• 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low protein breakfast; Subject will eat a low protein breakfast and maintain their habitual physical activity.	Dietary supplement: Low protein breakfast; 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.
Experimental: High protein breakfast; Subject will eat a high protein breakfast and maintain their habitual physical activity.	Dietary supplement: High protein 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.
Experimental: Low protein breakfast and exercise training; 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 breakfast; 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.; Other: Exercise training; Participants will be asked to participate in organized exercise training 3 times per week.
Experimental: High protein breakfast and exercise training; 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 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.; Other: Exercise training; Participants will be asked to participate in organized exercise training 3 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat free mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks
Change in Lean body mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks
Change in Height (cm)	by stadiometer	12 weeks
Change in weight (kg)	Tanita Scale	12 weeks
Change in BMI (m^2/kg)	Measured by height in meters and weight in kg	12 weeks
Change in Waist circumference (cm)	by tape	12 weeks
Change in HbA1c	by fasting blood sample	12 weeks
Change in high density lipoprotein cholesterol (HDL cholesterol)	by fasting blood sample	12 weeks
Change in low density lipoprotein cholesterol (LDL cholesterol)	by fasting blood sample	12 weeks
Change in triacylglycerol (TG)	by fasting blood sample	12 weeks
Change in total cholesterol	by fasting blood sample	12 weeks
Change in glucose	by fasting blood sample	12 weeks
Change in insulin	by fasting blood sample	12 weeks
Change in glucose tolerance (area under the curve)	measured by a two hour oral glucose tolerance test	12 weeks
Change in glucose peak	measured by a two hour oral glucose tolerance test	12 weeks
Change in fitness (estimated VO2-max)	Measured by Åstrand two-step bike test	12 weeks
Change in maximal hand grip strength	Measured by hand held dynamometer	12 weeks
Change in maximal arm strength	Measured by costummade dynamometer	12 weeks
Change in maximal jump height	Measured by squat jump with linear encoder	12 weeks
Change in systolic and diastolic blood pressure	by standard blood pressure apparatus	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	by accelerometry	12 weeks
Changes in dietary intake	by 4-day dietary registration	12 weeks
Changes in calcium and supplement intake	by a standard, validated food frequency questionnaire.	12 weeks
Change in gut microflora	by bacterial determination of faeces	12 weeks
Changes in faeces pH	by pH determination of faeces	12 weeks
Changes in urine metabolites	To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine samples will be collected to perform a metabolomics analysis by mass spectroscopy.	12 weeks
Changes in faeces metabolites	To evaluate the effect of the intervention on the metabolism through a metabolomic approach. Faeces samples will be collected to perform a metabolomics analysis by mass spectroscopy.	12 weeks
Changes in blood metabolites	To evaluate the effect of the intervention on metabolism through a metabolomic approach. Blood samples will be collected to perform a metabolomics analysis by mass spectroscopy.	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: body composition; Exercise training; Muscle strength; Dietary recommendations; Dairy protein; Breakfast content; Gut microbiota/microflora
• Additional Relevant MeSH Terms: Body Weight; Overweight; Metabolic Diseases
• Other Study ID Numbers: NyStart2

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