The Effect of Macronutrients in the Diet on Digestive and Cardiovascular Health
Effect of a 5-day Adaptation and Deadaptation Periods to a High-fat Diet Supplemented With Specific Fatty Acids on Gastrointestinal Transit, Appetite and Substrate Utilisation
1 other identifier
interventional
24
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2010
Shorter than P25 for not_applicable obesity
1 active site
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
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedJanuary 16, 2012
January 1, 2012
9 months
January 5, 2012
January 10, 2012
Conditions
Keywords
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
EXPERIMENTALemia oil
Dietary supplementation olive oil
EXPERIMENTALOlive oil
Dietary Supplementation fish oil
EXPERIMENTALfish oil
Interventions
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.
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.
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.
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Eligibility Criteria
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
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: 9854848BACKGROUNDGhoos 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amir Shafat, PhD
University of Limerick
- PRINCIPAL INVESTIGATOR
Oonagh Markey, BSc
University of Limerick
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