NCT02211612

Brief Summary

To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Shorter than P25 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

First Submitted

Initial submission to the registry

August 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

August 6, 2014

Last Update Submit

October 25, 2016

Conditions

ObesityOverfeedingMuscle MassBody CompositionEctopic Fat

Keywords

OverfeedingWeight gainLiver fatPancreatic fatEctopic fatSkeletal muscleAdipose tissueGene expressionDNA methylationPalmitateLinoleic acidSaturated fatPolyunsaturated fatMetabolismInsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Change in lean tissue mass

    Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)

    10 weeks

Secondary Outcomes (7)

  • Change in hepatic fat content

    10 weeks

  • Change in visceral adipose tissue (VAT)

    10 weeks

  • Change in total adipose tissue

    10 weeks

  • Change in pancreatic fat

    10 weeks

  • Change in insulin sensitivity

    10 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Circulating hormones and molecular analyses in muscle and fat tissue

    10 weeks

Study Arms (2)

Saturated fatty acids (SFA)-group

EXPERIMENTAL

Weight gain created by addition of muffins baked on saturated fat

Dietary Supplement: SFA-group

Polyunsaturated fatty acids (PUFA)-group

EXPERIMENTAL

Weight gain created by addition of muffins baked on polyunsaturated fat

Dietary Supplement: PUFA-group

Interventions

PUFA-groupDIETARY_SUPPLEMENT
Polyunsaturated fatty acids (PUFA)-group
SFA-groupDIETARY_SUPPLEMENT
Saturated fatty acids (SFA)-group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 25-32

You may not qualify if:

  • Type 2 diabetes
  • Type 1 diabetes
  • Kidney disease
  • Liver disease
  • Abnormal clinical chemistry at screening
  • Intense physical exercise \> 2 hours per week
  • Use of statins or drugs affecting energy metabolism
  • Use of extreme diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences

Uppsala, Please Select, 75185, Sweden

Location

Related Publications (3)

  • Rosqvist F, Cedernaes J, Martinez Mora A, Friden M, Johansson HE, Iggman D, Larsson A, Ahlstrom H, Kullberg J, Riserus U. Overfeeding polyunsaturated fat compared with saturated fat does not differentially influence lean tissue accumulation in individuals with overweight: a randomized controlled trial. Am J Clin Nutr. 2024 Jul;120(1):121-128. doi: 10.1016/j.ajcnut.2024.04.010. Epub 2024 Apr 16.

    PMID: 38636844DERIVED

  • 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

  • Rosqvist F, Kullberg J, Stahlman M, Cedernaes J, Heurling K, Johansson HE, Iggman D, Wilking H, Larsson A, Eriksson O, Johansson L, Straniero S, Rudling M, Antoni G, Lubberink M, Orho-Melander M, Boren J, Ahlstrom H, Riserus U. Overeating Saturated Fat Promotes Fatty Liver and Ceramides Compared With Polyunsaturated Fat: A Randomized Trial. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6207-6219. doi: 10.1210/jc.2019-00160.

    PMID: 31369090DERIVED

MeSH Terms

Conditions

ObesityWeight GainFatty LiverInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Ulf Riserus

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 7, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

SE(1)