Breakfast for Young Females

Overweight and Obesity Clinical Trial

— NyStart2  

Official title:

Breakfast for Young Females - the Importance of Breakfast Type

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518605
• Other study ID #: NyStart2
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 1, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Overweight
• Overweight Adolescents
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Sygekassernes Helsefond, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity	by accelerometry	12 weeks
Other	Changes in dietary intake	by 4-day dietary registration	12 weeks
Other	Changes in calcium and supplement intake	by a standard, validated food frequency questionnaire.	12 weeks
Other	Change in gut microflora	by bacterial determination of faeces	12 weeks
Other	Changes in faeces pH	by pH determination of faeces	12 weeks
Other	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
Other	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
Other	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
Primary	Change in Fat mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks
Secondary	Change in Fat free mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks
Secondary	Change in Lean body mass in grams	Measured by dual energy x-ray absorptiometry (DXA)	12 weeks
Secondary	Change in Height (cm)	by stadiometer	12 weeks
Secondary	Change in weight (kg)	Tanita Scale	12 weeks
Secondary	Change in BMI (m^2/kg)	Measured by height in meters and weight in kg	12 weeks
Secondary	Change in Waist circumference (cm)	by tape	12 weeks
Secondary	Change in HbA1c	by fasting blood sample	12 weeks
Secondary	Change in high density lipoprotein cholesterol (HDL cholesterol)	by fasting blood sample	12 weeks
Secondary	Change in low density lipoprotein cholesterol (LDL cholesterol)	by fasting blood sample	12 weeks
Secondary	Change in triacylglycerol (TG)	by fasting blood sample	12 weeks
Secondary	Change in total cholesterol	by fasting blood sample	12 weeks
Secondary	Change in glucose	by fasting blood sample	12 weeks
Secondary	Change in insulin	by fasting blood sample	12 weeks
Secondary	Change in glucose tolerance (area under the curve)	measured by a two hour oral glucose tolerance test	12 weeks
Secondary	Change in glucose peak	measured by a two hour oral glucose tolerance test	12 weeks
Secondary	Change in fitness (estimated VO2-max)	Measured by Åstrand two-step bike test	12 weeks
Secondary	Change in maximal hand grip strength	Measured by hand held dynamometer	12 weeks
Secondary	Change in maximal arm strength	Measured by costummade dynamometer	12 weeks
Secondary	Change in maximal jump height	Measured by squat jump with linear encoder	12 weeks
Secondary	Change in systolic and diastolic blood pressure	by standard blood pressure apparatus	12 weeks