- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427140
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- 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.
- 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. Erratum In: Am J Clin Nutr. 2017 Jul;106(1):325.
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLS-2011-LPG
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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