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

University of Kiel

Status: Completed

Conditions: Healthy

Treatments: Other: high protein diet; Other: moderate protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05337007

ABW-2022-HP

Details and patient eligibility

About

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).

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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))

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

dietary intervention, high protein diet

Experimental group

Description:

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

Treatment:

Other: high protein diet

dietary intervention, moderate protein diet

Active Comparator group

Description:

commercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions

Treatment:

Other: moderate protein diet