Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN) (LIPOGAIN)

December 8, 2011 updated by: Uppsala University

Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study

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.

Study Overview

Detailed Description

Specific goals:

  • Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain
  • Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain
  • Investigate effects of weight gain and dietary fat composition on markers of vascular health

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Uppsala, Sweden
        • Uppsala University Hospital, Uppsala Science Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy,
  • Body Mass Index 18-27

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saturated fatty acid group
Addition of saturated fatty acids to the diet inte the form of pastries
Addition of saturated fatty acids to the diet in the form of pastries
Active Comparator: Polyunsaturated fatty acid group
Addition of polyunsaturated fatty acids to the diet in the form of pastries
Addition of polyunsaturated fatty acids to the diet in the form of pastries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatic steatosis by magnetic resonance tomography (MRT)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cholesterol
Time Frame: 6 weeks
6 weeks
Triglycerides
Time Frame: 6 weeks
6 weeks
Insulin
Time Frame: 6 weeks
6 weeks
Glucose
Time Frame: 6 weeks
6 weeks
high density lipoprotein (HDL)
Time Frame: 6 weeks
6 weeks
low density lipoprotein (LDL)
Time Frame: 6 weeks
6 weeks
Apolipoprotein B (ApoB)
Time Frame: 6 weeks
6 weeks
Apolipoprotein A1 (ApoA1)
Time Frame: 6 weeks
6 weeks
Aspartate aminotransferase (ASAT)
Time Frame: 6 weeks
6 weeks
Alanine aminotransferase (ALAT)
Time Frame: 6 weeks
6 weeks
Gamma glutamyl transpeptidase (GGT)
Time Frame: 6 weeks
6 weeks
Homeostasis model of assessment insulin resistance (HOMA-IR)
Time Frame: 6 weeks
6 weeks
C-reactive protein (CRP)
Time Frame: 6 weeks
6 weeks
Proinsulin
Time Frame: 6 weeks
6 weeks
Endostatin
Time Frame: 6 weeks
6 weeks
Pentraxin-3 (PTX-3)
Time Frame: 6 weeks
6 weeks
Endothelin-1 (ET-1)
Time Frame: 6 weeks
6 weeks
E-selectin
Time Frame: 6 weeks
6 weeks
Cathepsin-S
Time Frame: 6 weeks
6 weeks
Cystatin C
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ulf Risérus, Ass. professor, Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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