Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance

Study Overview
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Brief Summary
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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
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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. 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 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

Official Title
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Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)

Conditions
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Healthy

Intervention / Treatment
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* Other: high protein diet
* Other: moderate protein diet


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: all subjects are undergoing each intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietary intervention, high protein diet<br>commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions | Other: high protein diet<br>* 48 hours intervention with a 'high protein' ad libitum diet (30 % protein; 80 % commercially available ultraprocessed foods) to measure energy balance in a metabolic chamber at physical activity level of 1.45<br>|
| Active Comparator: dietary intervention, moderate protein diet<br>commercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions | Other: moderate protein diet<br>* 48 hours intervention with a 'moderate protein' ad libitum diet (13 % protein; 80 % commercially available ultraprocessed foods) to measure energy balance in a metabolic chamber at physical activity level of 1.45<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ad libitum energy intake | ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks) | 24 hours | 
| energy expenditure | measured with indirect calorimetry in a metabolic chamber (kcal/day) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macronutrient oxidation | measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ) | 24 hours | 
| glycemia - glucose AUC | glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours) | 24 hours | 
| eating rate | time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min) | 3 x 30 per 24 hours (during main meals) | 
| oral processing behaviour (chewing) | chews per bite, bite size, oral exposure per bite | 3 x 30 per 24 hours (during main meals) | 
| gastric emptying | measured with 13C-octanoic acid breath test | 5 hours after breakfast on first day of each intervention; intervals 15 min | 
| appetite regulating hormone - ghrelin | Ghrelin concentration in plasma (15 hours AUC; pg/mL) | 5 hours after breakfast on second day of each intervention; intervals 30 min | 
| appetite regulating hormone - GLP-1 | Glucose Like Peptide-1 concentration in plasma (15 hours AUC; pg/mL) | 5 hours after breakfast on second day of each intervention; intervals 30 min | 
| appetite regulating hormone - PYY | Peptide YY concentration in plasma (15 hours AUC; pg/mL) | 5 hours after breakfast on second day of each intervention; intervals 30 min | 
| appetite control - subjective feelings of hunger | measured with visual analogue scales (5 hours AUC; mm x 5 hours). The scale consists of a 10 cm vertical line anchored with not hungry at all at the left side and with extremely hungry at the right side. | 5 hours after breakfast on first day of each intervention; intervals 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high protein foods, ultraprocessed foods, ad libitum energy intake, metabolic chamber, energy balance, macronutrient oxidation, appetite control