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Food Structure and Satiety (StrucSat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04289883
Recruitment Status : Withdrawn (The Covid-19 pandemic that made it impossible to conduct within the timeframe.)
First Posted : February 28, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
University of Copenhagen
Technical University of Denmark
DuPont Nutrition and Health
Arla Foods
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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).

Condition or disease Intervention/treatment Phase
Appetitive Behavior Combination Product: Nano-particulated whey protein vs non-particulated whey protein (control) Combination Product: High molecular weight whey protein-alginate coacervates vs calcium alginate (control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A double-blind, randomised crossover design with four arms divided into two parts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Prevention
Official Title: Nano-particulated and Alginate Whey Protein's Effects on Appetite - Food Structure Approaches Developed Within the StrucSat Project
Estimated Study Start Date : April 25, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: High molecular weight whey protein-alginate/Calcium alginate
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)
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.

Experimental: Nano-particulated whey protein/Non-particulated whey protein
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)
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.




Primary Outcome Measures :
  1. 24-hour energy intake (kJ) [ Time Frame: 24 hour ]
    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.


Secondary Outcome Measures :
  1. Energy intake (kJ) at each of the ad libitum meals [ Time Frame: Lunch: 30 minutes; Snack box: from 12.00 pm until going to bed (app. 11 hour) ]
    Difference in energy intake at each of the ad libitum meals (lunch and snack box) between exposure to the experimental conditions compared to the matching control conditions.

  2. Visual analogue scales (VAS) of self-reported appetite assessed throughout the appetite probe days while being in the laboratory [ Time Frame: 3 hour ]
    Difference in perceptions of satiety, fullness, hunger and predicted prospective food consumption between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating no hunger or perccieved ability to consume food / no satiety or no fullness).

  3. Satiety quotient (SQ) [ Time Frame: 30 minutes ]
    Difference in SQ between exposure to the experimental conditions compared to the matching control conditions is assessed by analysing the VAS assessments before and after the ad libitum lunch in relation to the energy consumed at the test meal will be assessed.

  4. Visual analogue scales of self-reported nausea and well-being assessed throughout the appetite probe days while being in the laboratory [ Time Frame: 3 hour ]
    Difference in perceptions of nausea and well-being between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating no nausea).

  5. Visual analogue scales of self-reported product palatability [ Time Frame: 5 minutes (assessed after both exposures at each appetite probe day) ]
    Difference in perceptions of palatability of the test products between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating low palatability of the product).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-reporting
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289883


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg, Denmark, 1958
Sponsors and Collaborators
Arne Astrup
University of Copenhagen
Technical University of Denmark
DuPont Nutrition and Health
Arla Foods
Investigators
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Principal Investigator: Anders Sjödin, PhD University of Copenhagen, Department of Nutrition, Exercise and Sports
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Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04289883    
Other Study ID Numbers: B311
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arne Astrup, University of Copenhagen:
Satiety
Appetite
Food structure
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs