The Effect of Macronutrients in the Diet on Digestive and Cardiovascular Health

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510223
• Other study ID #: NutrientGastEmpt
• Status: Completed
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 10, 2012
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Obesity

Intervention

Dietary Supplement:
• Olive 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. 90 g olive oil added to the supplement for the purpose of the HF intervention phase.
• Olive oil and fish powder
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.
• Olive oil and macadamia 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.
• Deadaptation
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Appetite	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.	Within the first 6.5 hours after a meal	No
Secondary	substrate utilization	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.	Within the first 6.5 hours after a meal	No
Secondary	Food intake by buffet meal	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	No