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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337007
• Other study ID #: ABW-2022-HP
• Status: Completed
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: April 21, 2023

Study information

• Verified date: October 2023
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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))

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ad libitum energy intake	ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)	24 hours
Primary	energy expenditure	measured with indirect calorimetry in a metabolic chamber (kcal/day)	24 hours
Secondary	macronutrient oxidation	measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)	24 hours
Secondary	glycemia - glucose AUC	glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)	24 hours
Secondary	eating rate	time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min)	3 x 30 per 24 hours (during main meals)
Secondary	oral processing behaviour (chewing)	chews per bite, bite size, oral exposure per bite	3 x 30 per 24 hours (during main meals)
Secondary	gastric emptying	measured with 13C-octanoic acid breath test	5 hours after breakfast on first day of each intervention; intervals 15 min
Secondary	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
Secondary	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
Secondary	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
Secondary	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