NCT01466816

Brief Summary

Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity. Objective:

  1. 1.The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.
  2. 2.The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.
  3. 3.1 test meal
  4. 4.3 test meals with a different fatty acid composition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

October 19, 2011

Last Update Submit

November 3, 2011

Conditions

ObesityInsulin Resistance

Keywords

Lipid metabolism

Outcome Measures

Primary Outcomes (2)

  • Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity

    The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on postprandial insulin sensitivity will be measured during the stable isotope test.

    the individual participants will be measured within 8-10 weeks.

  • Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling

    Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids

    the individual participants will be measured within 8-10 weeks.

Secondary Outcomes (2)

  • Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling

    the individual participants will be measured within 8-10 weeks.

  • Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies

    the individual participants will be measured within 8-10 weeks.

Study Arms (3)

Saturated fatty acid test meal

EXPERIMENTAL
Dietary Supplement: test meals with various fatty acid compositions

Monounsaturated fatty acid meal

EXPERIMENTAL
Dietary Supplement: test meals with various fatty acid compositions

Polyunsaturated fatty acid meal

EXPERIMENTAL
Dietary Supplement: test meals with various fatty acid compositions

Interventions

test meals with various fatty acid compositionsDIETARY_SUPPLEMENT

Three different milkshakes with a U13C palmitate tracer added

Monounsaturated fatty acid mealPolyunsaturated fatty acid mealSaturated fatty acid test meal

Eligibility Criteria

Age35 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese males aged between 35 and 70 years with insulin resistance.

You may not qualify if:

  • History of type 2 diabetes.
  • Liver or kidney failure.
  • Diseases in which the live expectation is shorter then 5 years.
  • The use of experimental medication.
  • Diseases/medication use that may have an influence on the glucose tolerance.
  • Not to be able to understand the study information.
  • Users of fatty acid supplements including fish oils etc.
  • Users of high doses of antioxidant vitamins.
  • Athletes.
  • People on a diet of people that are planning to lose weight.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre +

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.

    PMID: 22338035DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Ellen E Blaak, PhD, Prof

    Maastricht University Medical Centre +

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

November 8, 2011

Study Start

October 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

NL(1)