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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05337007
Enrollment
24
Registered
2022-04-20
Start date
2022-05-04
Completion date
2023-04-21
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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

Interventions

OTHERhigh protein diet

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

OTHERmoderate protein diet

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

Sponsors

University of Kiel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

all subjects are undergoing each intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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))

Design outcomes

Primary

MeasureTime frameDescription
ad libitum energy intake24 hoursad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)
energy expenditure24 hoursmeasured with indirect calorimetry in a metabolic chamber (kcal/day)

Secondary

MeasureTime frameDescription
eating rate3 x 30 per 24 hours (during main meals)time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min)
oral processing behaviour (chewing)3 x 30 per 24 hours (during main meals)chews per bite, bite size, oral exposure per bite
gastric emptying5 hours after breakfast on first day of each intervention; intervals 15 minmeasured with 13C-octanoic acid breath test
macronutrient oxidation24 hoursmeasured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)
appetite regulating hormone - GLP-15 hours after breakfast on second day of each intervention; intervals 30 minGlucose Like Peptide-1 concentration in plasma (15 hours AUC; pg/mL)
appetite regulating hormone - PYY5 hours after breakfast on second day of each intervention; intervals 30 minPeptide YY concentration in plasma (15 hours AUC; pg/mL)
appetite control - subjective feelings of hunger5 hours after breakfast on first day of each intervention; intervals 30 minmeasured 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.
appetite regulating hormone - ghrelin5 hours after breakfast on second day of each intervention; intervals 30 minGhrelin concentration in plasma (15 hours AUC; pg/mL)
glycemia - glucose AUC24 hoursglucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026