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)

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: high protein diet; Other: moderate protein diet

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Institute of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary intervention, high protein diet; commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions	Other: high 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
Active Comparator: dietary intervention, moderate protein diet; commercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions	Other: moderate 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
macronutrient oxidation	measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)	24 hours
glycemia - glucose AUC	glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)	24 hours
eating rate	time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min)	3 x 30 per 24 hours (during main meals)
oral processing behaviour (chewing)	chews per bite, bite size, oral exposure per bite	3 x 30 per 24 hours (during main meals)
gastric emptying	measured with 13C-octanoic acid breath test	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)	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)	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)	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.	5 hours after breakfast on first day of each intervention; intervals 30 min

Collaborators and Investigators

• Sponsor: University of Kiel
• Investigators: Principal Investigator: Anja Bosy-Westphal, PhD, MD, Institute of Human Nutrition, Kiel University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: appetite control; macronutrient oxidation; energy balance; metabolic chamber; high protein foods; ultraprocessed foods; ad libitum energy intake
• Other Study ID Numbers: ABW-2022-HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No