Clinical trial NCT04652713: Breakfast for Young Women
Official title: Breakfast for Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Wolman Disease
Nutrition
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
First posted: 2020-12-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind randomized crossover trail with three intervention meals.
Primary purpose: PREVENTION

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.

Detailed description: This study is a single-blind randomized Cross-Over trial with 30 women aged 18-30 years, each completing three trials. Participants will consume either dairy-based protein-rich breakfast, isocaloric, fiber matched, fat matched, carbohydrate-rich breakfast or no breakfast in randomized order. Three hours later a standardized ad libitum lunch will be served.

Blood samples will be collected (pre, 10 min, 30 min, 60 min, 120 min, 175 min after breakfast) and VAS rating hunger, satiety and desire to eat will be determined (pre, during breakfast, 10, 30, 60, 90, 120, 180 min, during lunch, after lunch). Twenty-four hour food logs on the day before the test day and on the test day will be collected.

Participants will be characterized by determining height (cm), weight (kg), and body composition by a dual-energy X-ray (DXA) scan before the first test day.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Energy consumption on test days
timeFrame: 0-24 hours
Secondary outcomes:
measure: Change in hunger
timeFrame: 0-3 hours
measure: Change in satiety
timeFrame: 0-3 hours
measure: change in desire
timeFrame: 0-3 hours
measure: Change in ghrelin
timeFrame: 0-3 hours
measure: Change in leptin
timeFrame: 0-3 hours
measure: Change in glucose-dependent insulinotropic polypeptide (GIP)
timeFrame: 0-3 hours
measure: Change in Peptide YY (PYY3-36)
timeFrame: 0-3 hours
measure: Change in insulin
timeFrame: 0-3 hours
measure: Change in glucagon
timeFrame: 0-3 hours
measure: Change in glucose
timeFrame: 0-3 hours
measure: Energy consumption the day before a test day (food registration)
timeFrame: 0-24 hours
Other outcomes:
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body composition fat
timeFrame: Baseline
measure: Body composition fat free
timeFrame: Baseline
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: