- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510223
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
Study Overview
Status
Conditions
Detailed Description
High-fat (HF) diets of as little as three days have been shown to accelerate GI transit. This study aimed to assess if 5-day HF supplemented diet varying in fatty acid composition were sufficient to accelerate GI transit, appetite responses and substrate utilisation and whether a 5-day deadaptation period to a HF diet would reverse the responses induced by adaptation to a HFD.
The study will be conducted in a randomized, single-blinded manner in 24 healthy subjects. Three 5-day interventions will each followed by a test trial. In the first intervention period (CON), normal diet was supplemented with low-fat (LF) milkshakes (272 kcal, 6 g fat). The second and third interventions will involve repeating previous diet along with HF (1082 kcal, 96 g fat) or LF milkshakes respectively. The three high-fat supplement groups that subjects will be randomized to are as follows: (1) olive oil (90 g oil), (2) olive oil + n-3 EPA/DHA fish powder blend or (3) olive oil + macadamia oil blend.
The effect of 5-day HF diet (daily milkshake supplement: 1082 kcal, 96 g fat) on gastric emptying and mouth to caecum transit time of a high-fat test will be measured using the 13C octanoic acid breath test and H2 inulin breath test respectively for six hours postprandially. During this time course, measurements of subjective appetite sensations by visual analogue scale and substrate utilization by indirect calorimetry were also collected. Subsequently, food intake will be measured using an ad libitum buffet meal.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limerick, Ireland, 12345
- University of Limerick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults aged 18-35 years
Exclusion Criteria:
- History of gastrointestinal-related conditions or gastrointestinal disturbance within 3 months of study entry
- diabetes mellitus
- cardiovascular disease
- Allergies to foods in study
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary supplementation macademia oil
emia oil
|
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.
Other Names:
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Names:
|
Experimental: Dietary supplementation olive oil
Olive oil
|
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Names:
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.
Other Names:
|
Experimental: Dietary Supplementation fish oil
fish oil
|
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying by 13C octanoic acid breath test
Time Frame: within the first 6.5 hours after ingesting high-fat test meal
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite
Time Frame: Within the first 6.5 hours after a meal
|
Satiety was measured using a 150mm VAS to detect changes in hunger, thirst, desire to eat, tiredness, fullness and cold.
Variables thirst, tiredness and cold were used to distract volunteers from analysis of their satiety status.
This was taken before breakfast, after breakfast, every 30 minutes throughout the six hours and following the buffet meal.
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Within the first 6.5 hours after a meal
|
substrate utilization
Time Frame: Within the first 6.5 hours after a meal
|
The Douglas Bag technique was employed to collect expired air samples.
VO2 and VCO2 were used to calculate substarte oxidation by satndard indirect calorimetry methods.
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Within the first 6.5 hours after a meal
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Food intake by buffet meal
Time Frame: Within 6.5 hours after a meal
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After six hours volunteers were given access to a buffet meal and instructed to eat ad libitum.
The buffet meal consisted of a 21 different types of foods and contained a wide variety of foods of varying macronutrient.
Foods were covertly weighed before and after presentation and the difference converted to macronutrient intake using food tables or manufacturers' data.
|
Within 6.5 hours after a meal
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amir Shafat, PhD, University of Limerick
- Principal Investigator: Oonagh Markey, BSc, University of Limerick
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NutrientGastEmpt
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