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Trial record 35 of 406 for:    PYY

Encapsulated Nutrients' Acute Effects on Appetite; ENcapsulated, lipiD, aminO, pRobiotic, SatiEty (ENDORSE)

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ClinicalTrials.gov Identifier: NCT03080909
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Biocare Copenhagen A/S
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE February 23, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date June 20, 2017
Actual Study Start Date  ICMJE March 28, 2017
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Reduced energy intake [ Time Frame: up to day 5 ]
Assessments of ad libitum test meal when exposed to one or more of the encapsulated nutrients compared to the placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03080909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • Subjective appetite sensations [ Time Frame: Six hours during each test day between test day 1, 2, 3, 4 and 5 (acute effect) ]
    Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)
  • Subjective appetite sensations in relation to energy consumed [ Time Frame: up to day 5 ]
    Assessing the appetite quotient (AQ)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2017)
  • Subjective nausea assessments [ Time Frame: Six hours during each test day between test day 1, 2, 3, 4 and 5 (acute effect) ]
    VAS assessments for nausea throughout the study test day
  • Subjective nausea assessments [ Time Frame: up to day 5 ]
    End of day questionnaire assessing feeling of nausea after leaving the study facility
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Encapsulated Nutrients' Acute Effects on Appetite; ENcapsulated, lipiD, aminO, pRobiotic, SatiEty
Official Title  ICMJE Encapsulated Nutrients' Acute Effects on Appetite
Brief Summary A double-blind, randomized crossover design with five arms including four experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible participants will be invited to five separate test days. The test days cannot be within the same week, however 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. Significant changes in diet, physical activity level (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from screening to completion of the last test day) results in exclusion of that subject.
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 and no alcohol at all from 8 pm the night before the test days) or intense physical activity compared to what they normally do is allowed. 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 test day (visit 6)), 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 standardization in a room away from the other participants before initiating each test day. Possible in-compliance with the standardization will be judged by the sub-investigator whether to result in re-scheduling of the visit or to be recorded as a protocol deviation.

Participants arrive at the study facility at 07:30 in the morning. Compliance with standardization is controlled along with registration of possible adverse events, use of concomitant medications and consumption of fermented milk products. During the test days, participants are settled together in an open office, where they are separated at individual tables. During the meals, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other.

Visual analogue scales (VAS') will be completed for measurement of fasting subjective appetite levels.

The test products (capsules) will be provided 30 minutes prior to a standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to a standardized fixed mid-morning snack (providing 1500 kJ). An ad libitum test meal will be provided 6 hour after first provision of capsules (time 0). There will be 2 hour interval between the two servings of capsules and 4 hour interval between the second serving of capsules and the ad libitum test meal.

Immediately before and after each episode of capsules and food consumption and at 30 minutes intervals, VAS' will be completed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A double-blind, randomized crossover design with five arms including four experimental conditions and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Prevention
Condition  ICMJE Appetite; Lack or Loss, Nonorganic Origin
Intervention  ICMJE
  • Dietary Supplement: Encapsulated nutrients
    Amino acid + Lipid; Probiotic bacteria; Lipid; Amino acid selected on their ability to stimulate release of GLP-1 and PYY
  • Dietary Supplement: Placebo
    Maltodextrin, which is not expected to stimulate release of GLP-1 and PYY
Study Arms  ICMJE
  • Active Comparator: Encapsulated nutients

    Encapsulated nutrients known to be able to stimulate GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum) expected to start approximately 3 hour following ingestion.

    The encapsulated nutrients will be provided 30 minutes prior to the standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to the standardized fixed mid-morning snack (providing 1500 kJ), i.e. test products will be provided 6 hour and 4 hour before the ad libitum test meal, respectively.

    Intervention: Dietary Supplement: Encapsulated nutrients
  • Placebo Comparator: Placebo

    Nutrients known to have limited stimulation on GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum) expected to start approximately 3 hour following ingestion.

    The placebo products will be provided 30 minutes prior to the standardized fixed breakfast (providing 2000 kJ) and 60 minutes prior to the standardized fixed mid-morning snack (providing 1500 kJ), i.e. placebo products will be provided 6 hour and 4 hour before the ad libitum test meal, respectively.

    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
33
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
30
Actual Study Completion Date  ICMJE June 8, 2017
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Selfreporting
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080909
Other Study ID Numbers  ICMJE B332
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared
Responsible Party Arne Astrup, University of Copenhagen
Study Sponsor  ICMJE Arne Astrup
Collaborators  ICMJE Biocare Copenhagen A/S
Investigators  ICMJE
Principal Investigator: Anders Sjödin, MD, PhD Department of Nutrition, Exercise and Sports
PRS Account University of Copenhagen
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP