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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amir Shafat, University of Limerick
ClinicalTrials.gov Identifier:
NCT01510223
First received: January 5, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Obesity
Diabetes
Cardiovascular Diseases
Dietary Supplement: Olive oil
Dietary Supplement: Olive oil and fish powder
Dietary Supplement: Olive oil and macadamia oil
Dietary Supplement: Deadaptation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University of Limerick:

Primary Outcome Measures:
  • Gastric emptying by 13C octanoic acid breath test [ Time Frame: within the first 6.5 hours after ingesting high-fat test meal ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Appetite [ Time Frame: Within the first 6.5 hours after a meal ] [ Designated as safety issue: No ]
    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.

  • substrate utilization [ Time Frame: Within the first 6.5 hours after a meal ] [ Designated as safety issue: No ]
    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.

  • Food intake by buffet meal [ Time Frame: Within 6.5 hours after a meal ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary supplementation macademia oil
emia oil
Dietary Supplement: 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.

Other Name: OM
Dietary Supplement: Deadaptation
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Name: DEADAPT
Experimental: Dietary supplementation olive oil
Olive oil
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.

Other Name: OO
Dietary Supplement: Deadaptation
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Name: DEADAPT
Experimental: Dietary Supplementation fish oil
fish oil
Dietary Supplement: 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.

Other Name: OF
Dietary Supplement: Deadaptation
A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
Other Name: DEADAPT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510223

Locations
Ireland
University of Limerick
Limerick, Ireland, 12345
Sponsors and Collaborators
University of Limerick
Investigators
Study Director: Amir Shafat, PhD University of Limerick
Principal Investigator: Oonagh Markey, BSc University of Limerick
  More Information

Publications:
Responsible Party: Amir Shafat, Lecturer, Study director,, University of Limerick
ClinicalTrials.gov Identifier: NCT01510223     History of Changes
Other Study ID Numbers: NutrientGastEmpt
Study First Received: January 5, 2012
Last Updated: January 10, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Limerick:
Fats
Macronutrients
appetite
gastric emptying
Gastrointestinal transit

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014