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Lipid Encapsulation for Ileal Brake Activation

The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03025997
Enrollment
33
Registered
2017-01-20
Start date
2017-01-24
Completion date
2017-03-31
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetite Regulation

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.

Interventions

DIETARY_SUPPLEMENTActive yoghurt

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

DIETARY_SUPPLEMENTPlacebo yoghurt

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

Sponsors

Wageningen University and Research
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
ad libitum food intake2 hours after yoghurt snackt=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake

Secondary

MeasureTime frameDescription
occurrence and severity of GI symptomsUp to 3.5 hours on each of the 2 test days.Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale
Satiety feelingsUp to 3.5 hours on each of the 2 test days.Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026