Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2020-04-25
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part 1: The objective of this part of the study is to examine if nano-particulated whey protein can reduce appetite compared with non-particulated whey protein.
Part 2: The objective of this part of the study is to examine if high molecular weight whey protein-alginate coacervates can reduce appetite compared to calcium alginate.
A double-blind, randomised crossover design with four arms divided into the two parts will be applied. After having successfully completed screening procedures, eligible participants will be invited to two separate appetite probe days with particulated whey protein followed by at least 14 days break followed by another two separate appetite probe days with the whey protein-alginate coacervates. The appetite probe days must be separated by at least 7 days, but there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level significantly. The study includes a total of five visits to the study site.
For standardisation, 48 hours before the appetite probe days, the participants will be asked to consume a regular diet compliant to what they usually eat and no excessive alcohol consumption (not above 5 units and no alcohol at all from 8 pm the night before the appetite probe days) or intense physical activity is allowed. Within each part of the study, the participants will be instructed to consume similar meals the evening before the appetite probe days and the meal must be consumed at approximately the same time. The participants will also be instructed to go to bed at the same time in the evening prior to the appetite probe days. Additionally, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation. Furthermore, over the course of the study (from screening (visit 1) to completion of the last appetite probe day (visit 5)), the participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardisation criteria in a room away from the other participants before initiating each appetite probe day. Possible non-compliance with the standardisation will be judged whether to result in re-scheduling of the visit or to be recorded as a protocol deviation.
Participants arrive at the study facility in the morning. Compliance with standardisation is controlled along with registration of possible adverse events and use of concomitant medications. During the appetite probe days, participants are settled together in an open office, where they are separated at individual tables. During the ad libitum lunch, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other.
VAS' will be completed for measurement of fasting levels of self-reported appetite.
The test products will be provided as a standardised fixed breakfast and as a standardised fixed mid-morning meal provided 3 hour and 1 hour prior to the ad libitum lunch, respectively.
Immediately before and after the test products and the ad libitum lunch and at 30 minutes intervals, VAS' will be completed assessing self-reported appetite.
After the ad libitum lunch, the participants will be free to leave the laboratory. They will be provided with a snack box including a variety of foods to including a ready-to-heat dish for dinner etc. providing approximately 10000 kJ. The participants will be instructed only to consume foods and drinks (water excepted) from the snack box for the remaining of the days, and to be focussed while eating and only eat until feeling comfortably full. The participants will be instructed to complete a diary registering the time point of consumption of which items from the snack box (and potential additional items). If consuming any foods or energy containing drinks besides those provided in the snack box, the participants will be instructed to register the type and amount consumed. Within the diary, the participants will also be instructed to register the time of going to bed on the day of the appetite probe day. At the second appetite probe day within each part of the study, the participants will be instructed to go to bed at approximately the same time as registered at the first appetite probe day within each part of the study. On the following day after each appetite probe day, the participants will be instructed to hand in the leftovers from the snack box and the diary at the research facility.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Copenhagen
OTHER
Technical University of Denmark
OTHER
DuPont Nutrition and Health
INDUSTRY
Arla Foods
INDUSTRY
Arne Astrup
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arne Astrup
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anders Sjödin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen, Department of Nutrition, Exercise and Sports
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B311
Identifier Type: -
Identifier Source: org_study_id