Food Structure and Satiety

NCT04289883 | Withdrawn DMC

• 1 other identifier: B311
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Based on in vitro studies identifying changes in food structures potential to delay digestion as well as results from animal studies showing potential of these foods to decrease appetite, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates were chosen to be investigated in humans. Thereby, the aim of this short-term study is to investigate if nano-particulated whey protein has appetite reducing effects in humans compared to non-particulated whey protein (Part 1) as well as if high molecular weight whey protein-alginate coacervates have appetite reducing effects in humans compared to calcium alginate (Part 2).

Conditions

Appetitive Behavior

Keywords

Satiety; Appetite; Food structure

Outcome Measures

Primary Outcomes (1)

• 24-hour energy intake (kJ)

  Difference in 24-hour energy intake (the total energy intake from the test products, the ad libitum lunch and the ad libitum snack box) between exposure to the experimental conditions compared to the matching control conditions.

  24 hour

Secondary Outcomes (5)

• Energy intake (kJ) at each of the ad libitum meals

  Lunch: 30 minutes; Snack box: from 12.00 pm until going to bed (app. 11 hour)

• Visual analogue scales (VAS) of self-reported appetite assessed throughout the appetite probe days while being in the laboratory

  3 hour

• Satiety quotient (SQ)

  30 minutes

• Visual analogue scales of self-reported nausea and well-being assessed throughout the appetite probe days while being in the laboratory

  3 hour

• Visual analogue scales of self-reported product palatability

  5 minutes (assessed after both exposures at each appetite probe day)

Study Arms (2)

High molecular weight whey protein-alginate/Calcium alginate

EXPERIMENTAL

Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly.

Combination Product: High molecular weight whey protein-alginate coacervates vs calcium alginate (control)

Nano-particulated whey protein/Non-particulated whey protein

EXPERIMENTAL

Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly.

Combination Product: Nano-particulated whey protein vs non-particulated whey protein (control)

Interventions

Nano-particulated whey protein vs non-particulated whey protein (control) COMBINATION_PRODUCT

Different particularisations of whey protein were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite and body weight based on animal studies compared to non-particulated whey protein, with nano-particulated whey protein suggested to be more efficient than micro-particulated.

Nano-particulated whey protein/Non-particulated whey protein

High molecular weight whey protein-alginate coacervates vs calcium alginate (control) COMBINATION_PRODUCT

Different whey protein-alginate coacervates were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite based on animal studies compared to calcium alginate, with high molecular weight alginate suggested to be more efficient than low molecular weight alginate.

High molecular weight whey protein-alginate/Calcium alginate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Self-reporting
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who have provided written informed consent
• Healthy men and women (at least 40% of each gender)
• Age between 18 and 45 years
• BMI between 22.0-30.0 kg/m2
• Regular breakfast eaters (eating breakfast ≥ 4 times a week)

You may not qualify if:

• Participants unable to consume the test products (the test product will be presented at screening)
• Participants not able to comply with the study protocol, including consumption of the specific study foods served during lunch and in the snack box (the study foods will be presented at screening)
• Any known food allergies or food intolerance likely to affect the present study
• Significant health problems as judged by the principal investigator
• Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study, as judged by the principal investigator
• Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
• Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
• Significant weight changes (±3 kg) over the course of the study (from screening to completion of last appetite probe day)
• Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last appetite probe day), as judged by the sub-investigator
• Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last appetite probe day) as judged by the sub-investigator
• Participants who work in appetite related areas
• Simultaneous or within the past month participating in other clinical trials that can interfere with the study

Sponsors & Collaborators

• Arne Astrup: lead
• University of Copenhagen: collaborator
• Technical University of Denmark: collaborator
• DuPont Nutrition and Health: collaborator
• Arla Foods: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Anders Sjödin, PhD

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A double-blind, randomised crossover design with four arms divided into two parts.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 28, 2020
• Study Start: April 25, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)