Clinical trial NCT05337007: Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance
Official title: Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: high protein foods
ultraprocessed foods
ad libitum energy intake
metabolic chamber
energy balance
macronutrient oxidation
appetite control
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: all subjects are undergoing each intervention
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of the study is to investigate the effects of high-protein, ultraprocessed foods on the regulation of energy balance in a metabolic chamber. The primary outcome parameter of the study is the energy balance (ad libitum energy intake and energy expenditure).

Detailed description: Each of the two study weeks starts with a 3-day run-in period with controlled diet at home, following 48 hours in a metabolic chamber. On the day the participants leave the metabolic chamber, they keep a food record over the rest of the day at home.

1. week: meals containing 30 % protein (80 % ultraprocessed high-protein foods), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake
2. week: meals containing 13 % protein (80 % ultraprocessed foods with moderate protein content), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake

Eligibility criteria: Inclusion Criteria:

* healthy
* BMI 19-29 kg/m2
* low-medium habitual physical activity
* women with regular menstrual cycle (during intervention in follicular phase)

Exclusion Criteria:

* smoking
* chronic illnesses (e.g. renal dysfunction)
* regular intake of medication
* food allergies / intolerances
* vegans and vegetarians
* regular high physical activity (exercise \>1 hour/d)
* current weight loss diet / weight loss of \>5 kg in the last 3 months
* pregnant / lactating women
* persons incapable of giving informed legal consent
* restraint eaters (according to the German version of the 'Three-Factor-Eating-Questionnaire', Stunkard und Messick (1985))

Primary outcomes:
measure: ad libitum energy intake
timeFrame: 24 hours
measure: energy expenditure
timeFrame: 24 hours
Secondary outcomes:
measure: macronutrient oxidation
timeFrame: 24 hours
measure: glycemia - glucose AUC
timeFrame: 24 hours
measure: eating rate
timeFrame: 3 x 30 per 24 hours (during main meals)
measure: oral processing behaviour (chewing)
timeFrame: 3 x 30 per 24 hours (during main meals)
measure: gastric emptying
timeFrame: 5 hours after breakfast on first day of each intervention; intervals 15 min
measure: appetite regulating hormone - ghrelin
timeFrame: 5 hours after breakfast on second day of each intervention; intervals 30 min
measure: appetite regulating hormone - GLP-1
timeFrame: 5 hours after breakfast on second day of each intervention; intervals 30 min
measure: appetite regulating hormone - PYY
timeFrame: 5 hours after breakfast on second day of each intervention; intervals 30 min
measure: appetite control - subjective feelings of hunger
timeFrame: 5 hours after breakfast on first day of each intervention; intervals 30 min
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition
Study officials:
affiliation: Institute of Human Nutrition, Kiel University
name: Anja Bosy-Westphal, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: