NCT03025997

Brief Summary

This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

November 20, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

January 6, 2017

Last Update Submit

November 16, 2017

Conditions

Appetite Regulation

Outcome Measures

Primary Outcomes (1)

  • ad libitum food intake

    t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake

    2 hours after yoghurt snack

Secondary Outcomes (2)

  • Satiety feelings

    Up to 3.5 hours on each of the 2 test days.

  • occurrence and severity of GI symptoms

    Up to 3.5 hours on each of the 2 test days.

Study Arms (2)

Active yoghurt

ACTIVE COMPARATOR

Yoghurt snack containing encapsulated lipid

Dietary Supplement: Active yoghurt

Placebo yoghurt

PLACEBO COMPARATOR

Yoghurt snack containing non-encapsulated lipid \+ empty encapsulation matrix

Dietary Supplement: Placebo yoghurt

Interventions

Active yoghurtDIETARY_SUPPLEMENT

Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Active yoghurt
Placebo yoghurtDIETARY_SUPPLEMENT

Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.

Placebo yoghurt

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 25-30 kg/m2
  • Voluntary participation

You may not qualify if:

  • Milk (-protein or lactose)- allergy/intolerance
  • History of serious GI complaints/surgeries
  • Pregnancy, lactation
  • Excessive alcohol consumption (\>20 per week)
  • Abnormal eating behaviour
  • Intention to stop smoking
  • Reported unexplained weight loss or gain in the month prior to screening
  • Self-admitted HIV-positive state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Study Officials

  • Adrian AM Masclee, Prof.

    azM/UM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 20, 2017

Study Start

January 24, 2017

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

November 20, 2017

Record last verified: 2017-03

Locations

NL(1)