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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

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.

Condition or disease Intervention/treatment Phase
Appetite; Lack or Loss, Nonorganic Origin Dietary Supplement: Encapsulated nutrients Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Official Title: Encapsulated Nutrients' Acute Effects on Appetite
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : June 8, 2017

Arm Intervention/treatment
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.

Dietary Supplement: Encapsulated nutrients
Amino acid + Lipid; Probiotic bacteria; Lipid; Amino acid selected on their ability to stimulate release of GLP-1 and PYY

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.

Dietary Supplement: Placebo
Maltodextrin, which is not expected to stimulate release of GLP-1 and PYY




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Subjective appetite sensations in relation to energy consumed [ Time Frame: up to day 5 ]
    Assessing the appetite quotient (AQ)


Other Outcome Measures:
  1. 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

  2. Subjective nausea assessments [ Time Frame: up to day 5 ]
    End of day questionnaire assessing feeling of nausea after leaving the study facility



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Selfreporting
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03080909


Locations
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Denmark
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, Denmark, 1958
Sponsors and Collaborators
Arne Astrup
Biocare Copenhagen A/S
Investigators
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Principal Investigator: Anders Sjödin, MD, PhD Department of Nutrition, Exercise and Sports

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Responsible Party: Arne Astrup, Professor, MD, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03080909     History of Changes
Other Study ID Numbers: B332
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
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
Nutrient
Appetite
Encapsulation
Lipid
Amino acid
Probiotic bacteria

Additional relevant MeSH terms:
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Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs