Status:
COMPLETED
Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)
Lead Sponsor:
Arne Astrup
Collaborating Sponsors:
Biocare Copenhagen A/S
Conditions:
Appetite; Lack or Loss, Nonorganic Origin
Eligibility:
MALE
18-60 years
Phase:
NA
Brief Summary
A double-blind, randomized crossover design with four arms including three experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible parti...
Detailed Description
For standardization, 48 hours before the test 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 ...
Eligibility Criteria
Inclusion
- Participants who have provided written informed consent
- Healthy men
- Age between 18 and 60 years
- BMI between 18.5-32 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Exclusion
- Participants unable to consume or known to get nausea from consuming 20 medium sized capsules (placebo capsules will be provided at screening for test of ability to consume the relevant amount of capsules)
- Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown 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 study professional
- Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) \< 4 weeks before study start
- Intake of probiotic supplements (any kind of supplements but not including foods containing probiotic) during the study
- Use of systemic medical treatment likely to interfere with evaluation of the study parameters 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 test 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 test 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 test 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03284554
Start Date
November 13 2017
End Date
February 15 2018
Last Update
February 19 2018
Active Locations (1)
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1
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, Denmark, 1958