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

NCT05337007 | Completed

• 1 other identifier: ABW-2022-HP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

high protein foods; ultraprocessed foods; ad libitum energy intake; metabolic chamber; energy balance; macronutrient oxidation; appetite control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• macronutrient oxidation

  24 hours

• glycemia - glucose AUC

  24 hours

• eating rate

  3 x 30 per 24 hours (during main meals)

• oral processing behaviour (chewing)

  3 x 30 per 24 hours (during main meals)

• gastric emptying

  5 hours after breakfast on first day of each intervention; intervals 15 min

Study Arms (2)

dietary intervention, high protein diet

EXPERIMENTAL

commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions

Other: high protein diet

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

Other: moderate protein diet

Interventions

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

dietary intervention, high protein diet

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

dietary intervention, moderate protein diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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))

Sponsors & Collaborators

• University of Kiel: lead

Study Sites (1)

Institute of Human Nutrition

Kiel, 24105, Germany

Location

Related Publications (1)

• 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.

  PMID: 40082711 DERIVED

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anja Bosy-Westphal, PhD, MD

  Institute of Human Nutrition, Kiel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Anja Bosy-Westphal

Model Details: all subjects are undergoing each intervention

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: May 4, 2022
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

DE (1)