NCT01478750

Brief Summary

Interaction of fat with the mouth, stomach and intestine will trigger physiological responses that will impact on the digestion, gut transit time and absorption of fat. These responses will also influence and contribute to regulation of food intake and satiety. No systematic research on understanding how the physiological-chemical properties of food affect the digestion and absorption of lipids has been carried out previously. Studies have shown that the release of free fatty acids triggers the fat-related responses. The investigators hypothesize that the release of fatty acids depends on the colloidal state of the fat, which changes progressively due to the pH changes and enzyme activities in the mouth, stomach and intestine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

1.4 years

First QC Date

November 14, 2011

Last Update Submit

October 24, 2012

Conditions

Obesity

Keywords

obesityfatappetitedigestion

Outcome Measures

Primary Outcomes (1)

  • Appearance of free fatty acids in the duodenum

    The appearance of free fatty acids in the duodenum will be assessed during the 180 min following ingestion of the test product.

    In the first 180 min after administration of test product

Secondary Outcomes (1)

  • Colloidal stability of fat

    In the first 180 min after administration of test product

Study Arms (4)

emulsified fat, orally

EXPERIMENTAL

At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80

Dietary Supplement: administration of fat (sunflower oil), emulsifiedProcedure: Insertion of nasoduodenal tube

intragastric administration of fat

EXPERIMENTAL

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically

Dietary Supplement: administration of fat (sunflower oil), emulsifiedProcedure: Insertion of nasoduodenal tube

intraduodenal administration of fat

EXPERIMENTAL

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally

Dietary Supplement: administration of fat (sunflower oil), emulsifiedProcedure: Insertion of nasoduodenal tube

intragastric, non-emulsified fat

EXPERIMENTAL

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically

Dietary Supplement: administration of fat (sunflower oil), emulsifiedProcedure: Insertion of nasoduodenal tube

Interventions

administration of fat (sunflower oil), emulsifiedDIETARY_SUPPLEMENT

40 ml sunflower oil, in the presence of the emulsifier tween-80.

emulsified fat, orallyintraduodenal administration of fatintragastric administration of fatintragastric, non-emulsified fat
Insertion of nasoduodenal tubePROCEDURE

A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat

Also known as: nasoduodenal intubation, nasoduodenal catheter
emulsified fat, orallyintraduodenal administration of fatintragastric administration of fatintragastric, non-emulsified fat

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent form
  • Sex: male or female
  • Age: 18-55 years
  • Body Mass Index (BMI): 18-29 kg/m2
  • Based on medical history and previous examination, no gastrointestinal complaints can be defined.

You may not qualify if:

  • Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/-connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/-psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol
  • Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit
  • Use of psychotropic drugs, including: benzodiazepines. Concomitant medication that can increase gastric pH (e.g. antacids, proton pump inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists), or alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgetics, adrenergic agents, calcium channel blockers), or alter intestinal transit (e.g., loperamide, chemical/osmotic/bulk laxatives) or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids), except oral contraceptives
  • Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment
  • Score \> 9 on Factor 1 (dietary restrained) of the Dutch translation of the Three Factor eating Questionnaire (TFEQ) \[17\]
  • Blood donations less than three months previous to study enrollment, and for three months following participation
  • One or more of the following dietary habits: medically prescribed diets, weight reduction diets, or vegetarian/macrobiotic/biologically dynamic food habits. Administration of investigational drugs in the 180 days prior to the study
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
  • Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, biological dynamic)
  • Excessive alcohol consumption (\>20 alcoholic consumptions per week)
  • Smoking
  • Self-admitted HIV-positive state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, NL-6200MD, Netherlands

Location

MeSH Terms

Conditions

ObesityPlatelet Glycoprotein IV Deficiency

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Freddy Troost, PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 23, 2011

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

NL(1)