Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)

NCT03284554 | Completed DMC

• 1 other identifier: B342
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 participants will be invited to four 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.

Conditions

Appetite; Lack or Loss, Nonorganic Origin

Keywords

Satiety; Nutrients; Appetite; Encapsulation; Lipid; Amino acid; Probiotic bacteria

Outcome Measures

Primary Outcomes (1)

• Reduced energy intake

  Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo

  up to day 4

Secondary Outcomes (2)

• Subjective appetite sensations

  Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)

• Subjective appetite sensations in relation to energy consumed

  up to day 4

Other Outcomes (2)

• Subjective nausea assessments

  Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)

• Subjective nausea assessments

  up to day 4

Study Arms (3)

Encapsulated nutients

ACTIVE COMPARATOR

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). The encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Dietary Supplement: Encapsulated nutrients

Non-encapsulated nutrients

SHAM COMPARATOR

Nutrients known to be able to stimulate GLP-1 and PYY release if they are encapsulated to provide release at pH ≈7.0 (in the distal part of the ileum). The same capsules in a non-coated form will be provided in order to study the effect of the coating. The non-encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Dietary Supplement: Non-encapsulated nutrients

Placebo

PLACEBO COMPARATOR

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). The placebo capsules will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.

Dietary Supplement: Placebo

Interventions

Encapsulated nutrients DIETARY_SUPPLEMENT

Amino acid + Lipid; Probiotic bacteria

Encapsulated nutients

Non-encapsulated nutrients DIETARY_SUPPLEMENT

Amino acid + Lipid; Probiotic bacteria

Non-encapsulated nutrients

Placebo DIETARY_SUPPLEMENT

Nutrient not expected to stimulate release of GLP-1 and PYY

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Selfreporting
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arne Astrup: lead
• Biocare Copenhagen A/S: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Location

Study Officials

• Anders Sjödin, MD, PhD

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: A double-blind, randomized crossover design with four arms including three experimental conditions and placebo

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: November 13, 2017
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)