NCT01038102

Brief Summary

The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 13, 2010

Status Verified

December 1, 2009

Enrollment Period

1.2 years

First QC Date

December 21, 2009

Last Update Submit

July 12, 2010

Conditions

ObesityDiabetesInsulin ResistanceFatty Liver

Keywords

ObesityDiabetesInsulin resistanceFatty liverNAFLDSteatosisDietary fatty acids

Outcome Measures

Primary Outcomes (1)

  • Hepatic steatosis by MRT

    10 weeks

Secondary Outcomes (2)

  • Insulin resistance by oral glucose tolerance test

    10 weeks

  • Changes in adipose tissue gene expression and lipogenic enzyme activity

    10 weeks

Study Arms (2)

PUFA diet

ACTIVE COMPARATOR

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)

Other: PUFA Diet

SFA diet

ACTIVE COMPARATOR

Diet high in saturated fat (15 E%)

Other: SFA diet

Interventions

PUFA DietOTHER

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).

PUFA diet
SFA dietOTHER

Diet high in saturated fat (15E%)

SFA diet

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • abdominal obese subjects with or without type 2 diabetes
  • sagittal abdominal diameter \>25cm

You may not qualify if:

  • insulin treatment
  • history of serious cardiovascular events
  • morbid obesity
  • claustrophobia (relative criterion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Uppsala Science Park

Uppsala, 75185, Sweden

Location

Related Publications (3)

  • Summers LK, Fielding BA, Bradshaw HA, Ilic V, Beysen C, Clark ML, Moore NR, Frayn KN. Substituting dietary saturated fat with polyunsaturated fat changes abdominal fat distribution and improves insulin sensitivity. Diabetologia. 2002 Mar;45(3):369-77. doi: 10.1007/s00125-001-0768-3.

    PMID: 11914742BACKGROUND

  • Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.

    PMID: 16179270BACKGROUND

  • Bjermo H, Iggman D, Kullberg J, Dahlman I, Johansson L, Persson L, Berglund J, Pulkki K, Basu S, Uusitupa M, Rudling M, Arner P, Cederholm T, Ahlstrom H, Riserus U. Effects of n-6 PUFAs compared with SFAs on liver fat, lipoproteins, and inflammation in abdominal obesity: a randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1003-12. doi: 10.3945/ajcn.111.030114. Epub 2012 Apr 4.

    PMID: 22492369DERIVED

MeSH Terms

Conditions

ObesityDiabetes MellitusInsulin ResistanceFatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinismLiver DiseasesDigestive System Diseases

Study Officials

  • Ulf Risérus, PhD

    Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 13, 2010

Record last verified: 2009-12

Locations

SE(1)