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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary intervention, high protein diet | Experimental | commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions |
|
| dietary intervention, moderate protein diet | Active Comparator | commercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high protein diet | Other | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anja Bosy-Westphal, PhD, MD | Institute of Human Nutrition, Kiel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Nutrition | Kiel | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082711 | Derived | Hagele FA, Herpich C, Koop J, Grubbel J, Dorner R, Fedde S, Gotze O, Boirie Y, Muller MJ, Norman K, Bosy-Westphal A. Short-term effects of high-protein, lower-carbohydrate ultra-processed foods on human energy balance. Nat Metab. 2025 Apr;7(4):704-713. doi: 10.1038/s42255-025-01247-4. Epub 2025 Mar 13. |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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all subjects are undergoing each intervention
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| moderate protein diet | Other | 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 |
|
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |