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

NCT ID: NCT01510223

Last Updated: 2012-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Obesity; Diabetes; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Dietary supplementation macademia oil

emia oil

Group Type: EXPERIMENTAL

Olive oil and macadamia oil

Intervention Type: DIETARY_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.

Deadaptation

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary supplementation olive oil

Olive oil

Group Type: EXPERIMENTAL

Olive oil

Intervention Type: DIETARY_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.

Deadaptation

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary Supplementation fish oil

fish oil

Group Type: EXPERIMENTAL

Olive oil and fish powder

Intervention Type: DIETARY_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.

Deadaptation

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Deadaptation

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

OO; OF; OM; DEADAPT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Amir Shafat

Lecturer, Study director,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Shafat, PhD

Role: STUDY_DIRECTOR

University of Limerick

Oonagh Markey, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

University of Limerick

Limerick, Limerick, Ireland

Countries

Ireland

References

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.

Reference Type: BACKGROUND

PMID: 9854848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8500721 (View on PubMed)

Other Identifiers

NutrientGastEmpt

Identifier Type: -

Identifier Source: org_study_id