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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03080909
• Date of registration: 23/02/2017
• Prospective Registration: Yes
• Primary sponsor: Arne Astrup
• Public title: Encapsulated Nutrients' Acute Effects on Appetite; ENcapsulated, lipiD, aminO, pRobiotic, SatiEty ENDORSE
• Scientific title: Encapsulated Nutrients' Acute Effects on Appetite
• Date of first enrolment: March 28, 2017
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03080909
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Anders Sjödin, MD, PhD
• Affiliation: Department of Nutrition, Exercise and Sports

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Appetite; Lack or Loss, Nonorganic Origin

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Encapsulated nutrients

Primary Outcome(s)

Reduced energy intake [Time Frame: up to day 5]

Secondary Outcome(s)

Subjective appetite sensations [Time Frame: Six hours during each test day between test day 1, 2, 3, 4 and 5 (acute effect)]

Subjective appetite sensations in relation to energy consumed [Time Frame: up to day 5]

Secondary ID(s)

B332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biocare Copenhagen A/S