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Completed

NCT Number: NCT05337007

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

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).

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition

Kiel, 24105, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

High protein diet

Other

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

Other

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

Primary outcomes

  1. ad libitum energy intake

    Time frame: 24 hours

    ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)

  2. energy expenditure

    Time frame: 24 hours

    measured with indirect calorimetry in a metabolic chamber (kcal/day)

Secondary outcomes

  1. macronutrient oxidation

    Time frame: 24 hours

    measured with indirect calorimetry in a metabolic chamber (respiratory quotient, RQ)

  2. glycemia - glucose AUC

    Time frame: 24 hours

    glucose AUC from continuous glucose monitoring data (mg/dL x 24 hours)

  3. eating rate

    Time frame: 3 x 30 per 24 hours (during main meals)

    time to finish the meals (breakfast, lunch, dinner), (kcal/min; g/min)

  4. oral processing behaviour (chewing)

    Time frame: 3 x 30 per 24 hours (during main meals)

    chews per bite, bite size, oral exposure per bite

  5. gastric emptying

    Time frame: 5 hours after breakfast on first day of each intervention; intervals 15 min

    measured with 13C-octanoic acid breath test

  6. appetite regulating hormone - ghrelin

    Time frame: 5 hours after breakfast on second day of each intervention; intervals 30 min

    Ghrelin concentration in plasma (15 hours AUC; pg/mL)

  7. appetite regulating hormone - GLP-1

    Time frame: 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)

  8. appetite regulating hormone - PYY

    Time frame: 5 hours after breakfast on second day of each intervention; intervals 30 min

    Peptide YY concentration in plasma (15 hours AUC; pg/mL)

  9. appetite control - subjective feelings of hunger

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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