NCT01510223

Brief Summary

This study examined the effect of a 5-day HFD supplemented with specific fatty acids on gastrointestinal transit, appetite, food intake and substrate utilization. Another novel aspect of this chapter was examining whether a subsequent 5-day period was sufficient to reverse the effects of high-fat feeding on the aforementioned parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable obesity

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

August 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 5, 2012

Last Update Submit

January 10, 2012

Conditions

Keywords

FatsMacronutrientsappetitegastric emptyingGastrointestinal transit

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying by 13C octanoic acid breath test

    13CO2 breath samples were taken every 15 minutes for six hours. Breath samples for measurement of 13CO2 were analyzed using isotope ratio mass spectrometry and results were expressed relative to Vienna-PeeDee Belemnite. 13CO2 values were expressed as the excess amount in the breath above baseline and converted into moles. This was then fitted to a GE model developed by Ghoos et al. 1993. For all the data, r2 coefficient between the modeled and raw data was calculated and r2 \> 0.95. Latency phase (Tlat) and ascension time (Tasc) from Schommartz et al. 1998.

    within the first 6.5 hours after ingesting high-fat test meal

Secondary Outcomes (3)

  • Appetite

    Within the first 6.5 hours after a meal

  • substrate utilization

    Within the first 6.5 hours after a meal

  • Food intake by buffet meal

    Within 6.5 hours after a meal

Study Arms (3)

Dietary supplementation macademia oil

EXPERIMENTAL

emia oil

Dietary Supplement: Olive oil and macadamia oilDietary Supplement: Deadaptation

Dietary supplementation olive oil

EXPERIMENTAL

Olive oil

Dietary Supplement: Olive oilDietary Supplement: Deadaptation

Dietary Supplementation fish oil

EXPERIMENTAL

fish oil

Dietary Supplement: Olive oil and fish powderDietary Supplement: Deadaptation

Interventions

Olive oilDIETARY_SUPPLEMENT

Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart). The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water. High-fat milkshake supplements were consumed daily for five days before a test trial. 90 g olive oil added to the supplement for the purpose of the HF intervention phase.

Also known as: OO
Dietary supplementation olive oil
Olive oil and fish powderDIETARY_SUPPLEMENT

Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart). The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water. High-fat milkshake supplements were consumed daily for five days before a test trial. 86.67 g olive oil and 3.3 g of n-3 fish powder (500 mg EPA+DHA)added to the supplement for the purpose of the HF intervention phase.

Also known as: OF
Dietary Supplementation fish oil
Olive oil and macadamia oilDIETARY_SUPPLEMENT

Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart). The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water. High-fat milkshake supplements were consumed daily for five days before a test trial. 74.82 g olive oil and 15.18 g macadamia nut oil added to the supplement for the purpose of the HF intervention phase.

Also known as: OM
Dietary supplementation macademia oil
DeadaptationDIETARY_SUPPLEMENT

A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.

Also known as: DEADAPT
Dietary Supplementation fish oilDietary supplementation macademia oilDietary supplementation olive oil

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18-35 years

You may not qualify if:

  • History of gastrointestinal-related conditions or gastrointestinal disturbance within 3 months of study entry
  • diabetes mellitus
  • cardiovascular disease
  • Allergies to foods in study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Limerick, 12345, Ireland

Location

Related Publications (2)

  • Schommartz B, Ziegler D, Schadewaldt P. Significance of diagnostic parameters in [13C]octanoic acid gastric emptying breath tests. Isotopes Environ Health Stud. 1998;34(1-2):135-43.

    PMID: 9854848BACKGROUND
  • Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.

    PMID: 8500721BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes MellitusCardiovascular Diseases

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Amir Shafat, PhD

    University of Limerick

    STUDY DIRECTOR
  • Oonagh Markey, BSc

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Study director,

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 16, 2012

Study Start

August 1, 2010

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations