ObesityLIPOGAIN-2NCT02211612
Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation
A study testing PUFA-group and SFA-group in people with Obesity and Overfeeding, run by Uppsala University at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overfeeding, Muscle Mass
- What is being tested?
- PUFA-group and SFA-group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 25-32
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences
Uppsala, Please Select, 75185
About this study
Official title: Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)
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
- Conditions
- Obesity, Overfeeding, Muscle Mass, Body Composition, Ectopic Fat
- Being tested
- PUFA-group, SFA-group
- Keywords
- Overfeeding, Weight gain, Liver fat, Pancreatic fat, Ectopic fat, Skeletal muscle, Adipose tissue, Gene expression, DNA methylation, Palmitate, Linoleic acid, Saturated fat, Polyunsaturated fat, Metabolism, Insulin sensitivity
- Medical subject headings
- Obesity, Weight Gain, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA-groupDietary supplement
SFA-groupDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Saturated fatty acids (SFA)-group | Experimental | Weight gain created by addition of muffins baked on saturated fat Receives: Dietary Supplement: SFA-group |
| Polyunsaturated fatty acids (PUFA)-group | Experimental | Weight gain created by addition of muffins baked on polyunsaturated fat Receives: Dietary Supplement: PUFA-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean tissue mass
Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)
Measured: 10 weeks
Secondary outcomes (7)
Change in hepatic fat content
Assessed by magnetic resonance imaging (MRI)
Measured: 10 weeks
Change in visceral adipose tissue (VAT)
Assessed by magnetic resonance imaging (MRI)
Measured: 10 weeks
Change in total adipose tissue
Assessed by magnetic resonance imaging (MRI)
Measured: 10 weeks
Change in pancreatic fat
Assessed by MRI
Measured: 10 weeks
Change in insulin sensitivity
Assessed by oral glucose tolerance test (OGTT)
Measured: 10 weeks
Change in plasma lipids
Plasma cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoprotein B, apolipoprotein A1, free fatty acids, glycerol, proprotein convertase subtilisin/kexin type 9
Measured: 10 weeks
Change in circulating inflammation and coagulation markers
Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, David Iggman, Uppsala University
- Investigators
- Ulf Riserus, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211612
- Sponsor's protocol ID
- LIPOGAIN-2
- Acronym
- LIPOGAIN-2
- Status last verified
- Oct 2016
- First submitted
- 6 Aug 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38636844Rosqvist 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.
PubMed 33344496Rosqvist 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.
PubMed 31369090
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)
- ClinicalTrials.gov ID
- NCT02211612
- Acronym / sponsor ID
- LIPOGAIN-2 / LIPOGAIN-2
- Conditions
- Obesity, Overfeeding, Muscle Mass, Body Composition, Ectopic Fat
- Keywords
- Overfeeding, Weight gain, Liver fat, Pancreatic fat, Ectopic fat, Skeletal muscle, Adipose tissue, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saturated fatty acids (SFA)-group | Experimental | Dietary Supplement: SFA-groupWeight gain created by addition of muffins baked on saturated fat |
| Polyunsaturated fatty acids (PUFA)-group | Experimental | Dietary Supplement: PUFA-groupWeight gain created by addition of muffins baked on polyunsaturated fat |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index 25-32
Key exclusion criteria (8 listed)
- Type 2 diabetes
- Type 1 diabetes
- Kidney disease
- Liver disease
- Abnormal clinical chemistry at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUFA-group | Dietary supplement | Polyunsaturated fatty acids (PUFA)-group |
| SFA-group | Dietary supplement | Saturated fatty acids (SFA)-group |
Primary outcome
Change in lean tissue mass
Time frame: 10 weeks
Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)
7 secondary outcomes
Change in hepatic fat content
Time frame: 10 weeks
Change in visceral adipose tissue (VAT)
Time frame: 10 weeks
Change in total adipose tissue
Time frame: 10 weeks
Change in pancreatic fat
Time frame: 10 weeks
Change in insulin sensitivity
Time frame: 10 weeks
Change in plasma lipids
Time frame: 10 weeks
Change in circulating inflammation and coagulation markers
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 38636844Rosqvist 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.
- Derived from this study: PubMed 33344496Rosqvist 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.
- Derived from this study: PubMed 31369090Rosqvist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Riserus principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUFA-group and SFA-group in people with Obesity and Overfeeding, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean tissue mass (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211612, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016; AzTrials last refreshed its copy on 26 Oct 2026.