NCT01427140

Brief Summary

The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

August 19, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

August 19, 2011

Last Update Submit

December 8, 2011

Conditions

Healthy

Keywords

Liver fatPolyunsaturated fatty acids (PUFA)Saturated fatty acids (SFA)Weight gainOverfeedDietary fatty acidsPalm oilSunflower oil

Outcome Measures

Primary Outcomes (1)

  • Hepatic steatosis by magnetic resonance tomography (MRT)

    6 weeks

Secondary Outcomes (20)

  • high density lipoprotein (HDL)

    6 weeks

  • low density lipoprotein (LDL)

    6 weeks

  • Insulin

    6 weeks

  • Glucose

    6 weeks

  • Triglycerides

    6 weeks

  • +15 more secondary outcomes

Study Arms (2)

Saturated fatty acid group

ACTIVE COMPARATOR

Addition of saturated fatty acids to the diet inte the form of pastries

Other: Saturated fatty acid group

Polyunsaturated fatty acid group

ACTIVE COMPARATOR

Addition of polyunsaturated fatty acids to the diet in the form of pastries

Other: Polyunsaturated fatty acid group

Interventions

Polyunsaturated fatty acid groupOTHER

Addition of polyunsaturated fatty acids to the diet in the form of pastries

Polyunsaturated fatty acid group
Saturated fatty acid groupOTHER

Addition of saturated fatty acids to the diet in the form of pastries

Saturated fatty acid group

Eligibility Criteria

Age20 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy,
  • Body Mass Index 18-27

You may not qualify if:

  • Liver disease,
  • Coronary heart disease,
  • Diabetes mellitus,
  • Malignant diseases,
  • Alcohol or drug abuse,
  • Magnetic Resonance-incompatibility,
  • Abnormal clinical chemistry,
  • Use of drugs that significantly effects energy metabolism,
  • Heavy exercise,
  • Pregnancy or lactation,
  • Allergy of gluten, egg or milk protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Uppsala Science Park

Uppsala, Sweden

Location

Related Publications (3)

  • Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.

    PMID: 33344496DERIVED

  • Perfilyev A, Dahlman I, Gillberg L, Rosqvist F, Iggman D, Volkov P, Nilsson E, Riserus U, Ling C. Impact of polyunsaturated and saturated fat overfeeding on the DNA-methylation pattern in human adipose tissue: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):991-1000. doi: 10.3945/ajcn.116.143164. Epub 2017 Mar 8.

    PMID: 28275132DERIVED

  • Iggman D, Rosqvist F, Larsson A, Arnlov J, Beckman L, Rudling M, Riserus U. Role of dietary fats in modulating cardiometabolic risk during moderate weight gain: a randomized double-blind overfeeding trial (LIPOGAIN study). J Am Heart Assoc. 2014 Oct 15;3(5):e001095. doi: 10.1161/JAHA.114.001095.

    PMID: 25319187DERIVED

MeSH Terms

Conditions

Fatty LiverWeight Gain

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulf Risérus, Ass. professor

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

September 1, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations

SE(1)