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

Sponsor

University of Kiel (Other)

Overall Status

Recruiting

CT.gov ID

NCT05337007

Collaborator

(none)

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: high protein diet Other: moderate protein diet	N/A

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.

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
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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

all subjects are undergoing each interventionall subjects are undergoing each intervention

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 4, 2022

Anticipated Primary Completion Date :

Apr 18, 2023

Anticipated Study Completion Date :

Apr 18, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

macronutrient oxidation [24 hours]
measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)
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
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 - ghrelin [5 hours after breakfast on second day of each intervention; intervals 30 min]
Ghrelin concentration in plasma (15 hours AUC; pg/mL)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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))