HealthyNCT05337007
Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance
A study testing high protein diet and moderate protein diet in people with Healthy, run by University of Kiel at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- high protein diet and moderate protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 4 May 2022to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI 19-29 kg/m2
- low-medium habitual physical activity
- women with regular menstrual cycle (during intervention in follicular phase)
Who cannot join
- 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)
Show all 10Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)
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).
Read the 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.
- 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
- Conditions
- Healthy
- Being tested
- high protein diet, moderate protein diet
- Keywords
- high protein foods, ultraprocessed foods, ad libitum energy intake, metabolic chamber, energy balance, macronutrient oxidation, appetite control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein dietOther
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
moderate protein dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| dietary intervention, high protein diet | Experimental | commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions Receives: 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 Receives: Other: moderate protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad libitum energy intake
ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)
Measured: 24 hours
energy expenditure
measured with indirect calorimetry in a metabolic chamber (kcal/day)
Measured: 24 hours
Secondary outcomes (9)
macronutrient oxidation
measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)
Measured: 24 hours
glycemia - glucose AUC
glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)
Measured: 24 hours
eating rate
time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min)
Measured: 3 x 30 per 24 hours (during main meals)
oral processing behaviour (chewing)
chews per bite, bite size, oral exposure per bite
Measured: 3 x 30 per 24 hours (during main meals)
gastric emptying
measured with 13C-octanoic acid breath test
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 5 hours after breakfast on first day of each intervention; intervals 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start4 May 2022
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- all subjects are undergoing each intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westphal, PhD, MD, Principal investigator, Institute of Human Nutrition, Kiel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337007
- Sponsor's protocol ID
- ABW-2022-HP
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40082711
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)
- ClinicalTrials.gov ID
- NCT05337007
- Acronym / sponsor ID
- ABW-2022-HP
- Conditions
- Healthy
- Keywords
- high protein foods, ultraprocessed foods, ad libitum energy intake, metabolic chamber, energy balance, macronutrient oxidation, appetite control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- all subjects are undergoing each intervention
| Arm | Type | Receives |
|---|---|---|
| dietary intervention, high protein diet | Experimental | Other: high protein dietcommercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions |
| dietary intervention, moderate protein diet | Active comparator | Other: moderate protein dietcommercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- BMI 19-29 kg/m2
- low-medium habitual physical activity
- women with regular menstrual cycle (during intervention in follicular phase)
Key exclusion criteria (10 listed)
- smoking
- chronic illnesses (e.g. renal dysfunction)
- regular intake of medication
- food allergies / intolerances
- vegans and vegetarians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high protein diet48 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 | Other | dietary intervention, high protein diet |
| moderate protein diet48 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 | Other | dietary intervention, moderate protein diet |
Primary outcome
ad libitum energy intake
Time frame: 24 hours
ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)
energy expenditure
Time frame: 24 hours
measured with indirect calorimetry in a metabolic chamber (kcal/day)
9 secondary outcomes
macronutrient oxidation
Time frame: 24 hours
glycemia - glucose AUC
Time frame: 24 hours
eating rate
Time frame: 3 x 30 per 24 hours (during main meals)
oral processing behaviour (chewing)
Time frame: 3 x 30 per 24 hours (during main meals)
gastric emptying
Time frame: 5 hours after breakfast on first day of each intervention; intervals 15 min
appetite regulating hormone - ghrelin
Time frame: 5 hours after breakfast on second day of each intervention; intervals 30 min
appetite regulating hormone - GLP-1
Time frame: 5 hours after breakfast on second day of each intervention; intervals 30 min
appetite regulating hormone - PYY
Time frame: 5 hours after breakfast on second day of each intervention; intervals 30 min
appetite control - subjective feelings of hunger
Time frame: 5 hours after breakfast on first day of each intervention; intervals 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 40082711Hagele 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Bosy-Westphal, PhD, MD principal investigator
Institute of Human Nutrition, Kiel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high protein diet and moderate protein diet in people with Healthy, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ad libitum energy intake (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.