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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT05337007
• Lead Sponsor: University of Kiel

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

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2022-05-04
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
ad libitum energy intake	24 hours	ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)
energy expenditure	24 hours	measured with indirect calorimetry in a metabolic chamber (kcal/day)

Secondary Outcome Measures

Name	Time	Method
macronutrient oxidation	24 hours	measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)
gastric emptying	5 hours after breakfast on first day of each intervention; intervals 15 min	measured with 13C-octanoic acid breath test
appetite regulating hormone - GLP-1	5 hours after breakfast on second day of each intervention; intervals 30 min	Glucose Like Peptide-1 concentration in plasma (15 hours AUC; pg/mL)
appetite regulating hormone - PYY	5 hours after breakfast on second day of each intervention; intervals 30 min	Peptide YY concentration in plasma (15 hours AUC; pg/mL)
appetite control - subjective feelings of hunger	5 hours after breakfast on first day of each intervention; intervals 30 min	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.
glycemia - glucose AUC	24 hours	glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)
eating rate	3 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
appetite regulating hormone - ghrelin	5 hours after breakfast on second day of each intervention; intervals 30 min	Ghrelin concentration in plasma (15 hours AUC; pg/mL)

Trial Locations

Locations (1)

Institute of Human Nutrition; 🇩🇪 Kiel, Germany