Acute Fatty Acid Intervention Study (AFAST)

Sponsor
Wageningen University (Other)
Overall Status
Completed
CT.gov ID
NCT01000194
Collaborator
Dutch Dairy Organization (NZO) (Other)
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Study Details

Study Description

Brief Summary

The main objective of this study is to elucidate whether different dietary fatty acids (SFA, PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC gene expression profiles. Secondary objectives are to elucidate the effects of these fat loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: High fat meal
N/A

Detailed Description

Nutrition plays a key role in the development of metabolic disorders like cardiovascular disease and the metabolic syndrome. Nutrients that can contribute to the risk of developing such diseases are fatty acids (FAs). It is known that fatty acids mediate their metabolic effects via changes in gene expression, through binding and subsequent activation of the transcription factor peroxisome proliferator-activated receptor (PPAR). In addition, it is known that unsaturated fatty acids are better ligands for PPAR than saturated fatty acids. Peripheral blood mononuclear cells (PBMC) express PPARalpha and are relatively easy to isolate from whole blood. We previously showed that the gene expression profiles of these cells can reflect free fatty acid increases during fasting. The question still remains whether dietary FA can influence gene expression in a similar way and, if so, whether different dietary FA result in different gene expression changes and subsequent activation of other pathways.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Acute Fatty Acid Intervention Study
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: High polyunsaturated fat meal

A high fat milkshake containing 55g of fat, mainly PUFA

Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat

Experimental: High monounsaturated fat meal

A high fat milkshake containing 55g of fat, mainly MUFA

Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat

Experimental: High saturated fat meal

A high fat milkshake containing 55g of fat, mainly SFA

Dietary Supplement: High fat meal
A high fat milkshake containing 55g of fat

Outcome Measures

Primary Outcome Measures

  1. Peripheral blood mononuclear cells (PBMC) gene expression profiles [0, 2, 4, 6, 8 hours]

Secondary Outcome Measures

  1. Plasma free fatty acid profiles [0, 6 hours]

  2. Plasma free fatty acids [0, 2, 4, 6, 8 hours]

  3. Plasma cholesterol [0, 2, 4, 6, 8 hours]

  4. Plasma triglycerides [0, 2, 4, 6, 8 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy Caucasian men

  • age between 18 and 30 years

Exclusion Criteria:
  • Allergic to fish oil

  • Allergic to margarine

  • Allergic to cow milk or dairy products

  • Current or recent (<4 weeks) use of fish oil supplements or more then four times fish/week; 24.35 g of EPA-DHA of fish per month (800 mg/day) as judged by the questionnaire.

  • Body mass index (BMI) < 18 or > 25 kg/m2

  • Urine glucose concentrations outside normal ranges (low to non-detectable)

  • Fasting blood glucose outside the normal range (3 - 5.5 mmol/L)

  • Tobacco smoking

  • Taking medication that may influence the study results

  • Received inoculations within 2 months of starting the study or planned to during the study

  • Donated or intended to donate blood from 2 months before the study till two months after the study

  • Diagnosed with any long-term medical condition (eg., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease)

  • Vegetarian

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wageningen University Wageningen Gelderland Netherlands 6700 AH

Sponsors and Collaborators

  • Wageningen University
  • Dutch Dairy Organization (NZO)

Investigators

  • Study Director: Lydia A Afman, PhD, Wageningen University
  • Study Chair: Michael Müller, PhD, Wageningen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01000194
Other Study ID Numbers:
  • NL19273.081.07
  • ABR19273
First Posted:
Oct 22, 2009
Last Update Posted:
Oct 22, 2009
Last Verified:
Oct 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2009