ObesityAlpha&OmegaNCT04279951
Alpha and Omega of Lifestyle Therapy
A study testing Resistance exercise and Omega-3 in people with Obesity, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
The study aims to investigate the effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of resistance training on muscle function/biology and systemic health in individuals with obesity (BMI>30) and lean individuals (BMI<30) Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Resistance exercise and Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 2 Sep 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Untrained (less than 2 sessions of resistance exercise per month and less than 3 hours of endurance exercise per week)
Who cannot join
- Unstable cardiovascular disease
- Injuries affecting the ability to perform heavy resistance exercise
- Mental illness
- Allergy to local anesthesia
- Smoking
- Use of medicine or drugs containing steroids the last two months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alpha and Omega of Lifestyle Therapy - Resistance Training and Ingestion of n-3 Polyunsaturated Fatty Acids to Improve Health and Muscle Functions in Individuals With Obesity and Healthy Controls
The study aims to investigate the effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of resistance training on muscle function/biology and systemic health in individuals with obesity (BMI>30) and lean individuals (BMI<30)
Read the detailed description
Lifestyle therapy is important for treating lifestyle-related morbidities such as obesity. Such therapy often includes exercise and nutrition, and leads to improved health, functionality and quality of life. Unfortunately, obesity leads to adverse changes in the physiological milieu, including inflammation and altered nutritional status such as reduced omega-3:omega-6 ratios. Indeed, inadequate omega 3 levels are common even among lean individuals. This may negatively affect the outcome of lifestyle therapy with exercise, particularly those involving resistance training, contributing to the large heterogeneity seen in training responses. In accordance with this, many individuals (including both lean and obese subjects) fail to improve muscle biology/functions and health, including failure to increase muscle mass and strength, failure to improve glucose handling and inflammatory status. This makes general lifestyle therapy recommendations ineffective. Here, we investigate effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of low- and high-load resistance training on muscle growth/function/biology and health in individuals with obesity (BMI>30, n=60) and lean controls (BMI<30, n=60). Each participant will perform two different training protocols, one on each leg. The supplement period will commence 7 weeks prior to the onset of the strength training intervention to ensure adequate omega-3 biology at the onset of training. Analyses include assessment of the separate and combined effects of n3-supplementation and obesity on training responses to resistance training, measured as muscle mass, muscle strength/functionality, muscle biological traits, and systemic health variables such as hormone/inflammation/glucose biology, adipose tissue biology/mass, gut microbiome and health-related quality of life. The project will provide important insight into the feasibility of resistance training and n-3 fatty acid supplementation for treating individuals with obesity, paving the way for personalized lifestyle therapy.
The study has two defined main outcome measures, targeting the combined effects of omega-3 and strength training on i) muscle thickness of the thigh (measured using ultrasound; this main outcome measure targets the effects of the intervention on muscle growth), and ii) glucose tolerance (measured using an oral glucose test; this main outcome measure targets the effects of the intervention on improvements in health).
In our analytical approach, we will use a mixed model-approach to assess the main effects of the intervention, mainly defined as changes from before to after the resistance training intervention. Importantly, for health variables such as glucose tolerance, analyses will be performed by accounting for individual variation at baseline, as any beneficial effect can be expected to be higher/present only in individuals with a pathological/diseased starting point. Notably, for many variables, we will collect data from two additional time points (pre-supplementation and after two weeks of familiarization to training). These data will provide insight into additional perspectives, such as the effects of omega-3 intake-only on glucose tolerance, which will bring additional depth to our conclusions (these analyses are not necessarily specified in the Outcome Measures section). For other data, such as primary cultivation of skeletal muscle and muscle mitochondrial respiration, data will only be collected from a randomized subset of participants. For analyses of the effects of the intervention on obesity-related pathophysiologies and health-related quality of life, data from a group of non-intervention individuals will act as reference values (data sampled alongside the intervention). Finally, we will use regression analyses to explain individual differences in training responses, with particular emphasis on muscle hypertrophy/glucose tolerance and their mechanistic origin of nature.
2021/08: The number of anticipated participants was increased from 120 to 150 due to circumstances relating to the SARS-CoV-2 pandemic
- Conditions
- Obesity
- Being tested
- Resistance exercise, Omega-3, Placebo
- Keywords
- Resistance exercise, Omega 3
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
High-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training)
Omega-3Dietary supplement
Also called N-3 PUFA
1 gram of omega-3 per day for 20 weeks
PlaceboDietary supplement
1 gram of sunflower oleic oil per day for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Experimental | Intake of 1 gram omega-3 (capsules) per day for 20 weeks
+ high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training) Receives: Other: Resistance exercise; Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | Intake of 1 gram sunflower oleic oil (capsules) per day for 20 weeks
+ high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training) Receives: Other: Resistance exercise; Dietary Supplement: Placebo |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness, ultrasound
Muscle thickness of vastus lateralis and vastus intermedius measured using ultrasound
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Glucose tolerance
Glucose tolerance measured using an oral glucose tolerance test
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Secondary outcomes (48)
Lean body mass
Lean body mass measured using whole-body DXA scan
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Fat mass
Fat mass measured using whole-body DXA scan
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Visceral fat mass
Visceral fat mass measured using whole-body DXA scan
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, MRI
Thigh muscle cross sectional area/volume measured using magnetic resonance imaging (MRI)
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, immunohistochemistry
Fibre type-specific muscle-fibre cross-sectional area measured using immunohistochemistry
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, combined measure
Muscle mass of the legs measured as the weighted average of data from ultrasound, MRI, immunohistochemistry and DXA measurements
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle fibre type composition
Muscle fibre type composition measured using immunohistochemistry
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Myonuclear number
Fiber type-specific myonuclear number measured using immunohistochemistry
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle satellite cell number
Fiber type-specific muscle satellite cell number measured using immunohistochemistry
Measured: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Muscle capillarization
Fiber type-specific muscle capillarization measured using immunohistochemistry
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Fat infiltration (muscle)
Fat infiltration in thigh muscle measured using magnetic resonance imaging (MRI)
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle quality
Muscle strength measured per muscle mass of the legs
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Unilateral lower body maximal strength
The ability of muscles of the lower body to exert maximal force during dynamic movements
Measured: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Unilateral lower body isokinetic muscle strength
The ability of the knee extensors to exert maximal force during isokinetic movements
Measured: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Unilateral lower body isometric muscle strength
The ability of the knee extensors to exert maximal force during isometric actions
Measured: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Peak power output during one-legged cycling
Maximal cycling performance measured as peak power output (Watt) during an incremental one-legged cycling test
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Oxygen consumption during one-legged cycling
The ability to consume oxygen during an incremental one-legged cycling test
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Unilateral lower body muscle endurance
The ability of muscles of the lower body to perform repeated dynamic contractions at a specified submaximal load (70% of 1RM) to exhaustion
Measured: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Waist circumference
Circumference of the waist measured using measuring tape
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Blood pressure at rest
Blood pressure at rest measured using an automated upper-arm blood pressure cuff
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Hemoglobin glycosylation (HbA1c)
Long-term glucose levels measured as hemoglobin glycosylation of the metabolic syndrome such as waist circumference, blood pressure at rest, lipid profile ( hemoglobin glycosylation (HbA1c) and fasting blood glucose
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Fasting blood glucose
Fasting blood glucose measured in serum
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
N-3 PUFA (blood)
Omega-3 (DHA/EPA) levels in blood
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Inflammatory characteristics of peripheral blood mononuclear cell (PBMC)
Expression of genes associated with inflammation and lipid metabolism in peripheral blood mononuclear cell measured using quantitative PCR
Measured: Throughout the course of the intervention (weeks 0, 8 and 20)
Lipid concentrations in blood
Concentrations of various lipids and lipid metabolites such as triglycerides, LDL, HDL, ceramides, dihydroceramides, glucosylceramides, and lactosylceramides measured in serum using tageted metabolomics
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Nutritent concentrations in blood
Concentrations of nutrients (such as amino acids) and ions (such as iron and calcium) measured in serum
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Hormone concentrations in blood
Concentrations of hormones such as testosterone, growth hormone, thyroid hormones, cortisol and insulin (as well as c-peptide) measured in serum
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Concentrations of inflammatory factors in blood
Levels of inflammatory factors such as IL6, CRP and NFkB in serum
Measured: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Muscle fractional synthesis rate
Protein/RNA synthesis rate measured using heavy water (deuterium) and chromatography/spectrometry
Measured: Week 18 to 20
Gene expression in skeletal muscle (intervention)
RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in m. vastus lateralis, measured both as targeted genes and at the level of the transcriptome
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Gene expression in skeletal muscle (familiarization)
RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in m. vastus lateralis, measured both as single genes and at the level of the transcriptome
Measured: Changes from before to after familiarization to resistance exercise (week 8 to 10)
Protein abundance in skeletal muscle (intervention)
Levels of proteins and their modification status (e.g. phosphorylation) in m. vastus lateralis, measured at the level of single proteins and at the level of the proteome
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Protein abundance in skeletal muscle (familiarization)
Levels of proteins and their modification status (e.g. phosphorylation) in m. vastus lateralis, measured at the level of single proteins and at the level of the proteome
Measured: Changes from before to after the resistance training intervention (week 8 to 10)
Mitochondrial functions in muscle
The ability of muscle mitochondria (extracted from muscle homogenate) to synthesize ATP in vitro
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Gene expression in subcutaneous fat
RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in subcutaneous fat, measured as targeted genes
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Satellite cell proliferation and myotube growth (in vitro)
The ability of muscle satellite cells (extracted from muscle homogenate) to proliferate (rates of cell division), differentiate into myotubes and subsequently grow (rates of change in myotube size) in primary cultures
Measured: Changes from before to after N3-supplementation-only (week 0 to 8)
Musculoskeletal pain (Nordic Pain Questionnaire)
Musculoskeletal pain measured using The standardized Nordic Pain Questionnaire
Measured: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Musculoskeletal pain (VAS)
Musculoskeletal pain measured using VAS-scale (1-10)
Measured: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Gastrointestinal symptoms
Gastrointestinal symptoms such as abdominal discomfort and pain, measured using Rome IV criteria
Measured: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Gut microbiome (feces, N3-supplementation-only)
Relative composition of the gut microbiome measured using quantitative polymerase chain reaction
Measured: Changes from before to after N3-supplementation-only (week 0 to 8)
Gut microbiome (feces, training intervention)
Relative composition of the gut microbiome measured using quantitative polymerase chain reaction
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Fecal short-chained fatty acids (N3-supplementation-only)
Short chained fatty acids measured in feces
Measured: Changes from before to after N3-supplementation-only (week 0 to 8)
Fecal short-chained fatty acids (training intervention)
Short chained fatty acids measured in feces
Measured: Changes from before to after the resistance training intervention (week 8 to 20)
Arterial stiffness
Arterial stiffness measured using pulse-wave velocity
Measured: Throughout the course of the intervention (week 0, 8 and 20)
Health-related quality of life (SF-36)
Health-related quality of life measured using the SF-36 questionnaire
Measured: Changes throughout the course of the intervention (week 0, 8 and 20)
Health-related quality of life in overweight/obesity
Health-related quality of life in overweight/obesity individuals measured using The impact of weight on quality of life (IWQOL) questionnaire
Measured: Changes throughout the course of the intervention (week 0, 8 and 20)
Health-related quality of life (PANAS)
Health-related quality of life measured using the Positive and Negative Affect Schedule (PANAS) questionnaire
Measured: Changes throughout the course of the intervention (week 0, 8 and 20)
Activities of daily living
Activities of daily living (e.g. time spent in physical activity, intensities of activities) measured using questionnaire
Measured: Changes throughout the course of the intervention (week 0, 8 and 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start2 Sep 2019
- Primary completion30 Mar 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stian Ellefsen, PhD, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279951
- Sponsor's protocol ID
- Trainome 2019#015
- Acronym
- Alpha&Omega
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha and Omega of Lifestyle Therapy - Resistance Training and Ingestion of n-3 Polyunsaturated Fatty Acids to Improve Health and Muscle Functions in Individuals With Obesity and Healthy Controls
- ClinicalTrials.gov ID
- NCT04279951
- Acronym / sponsor ID
- Alpha&Omega / Trainome 2019#015
- Conditions
- Obesity
- Keywords
- Resistance exercise, Omega 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Feb 2020 (actual)
- 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.
The study aims to investigate the effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of resistance training on muscle function/biology and systemic health in individuals with obesity (BMI>30) and lean individuals (BMI<30)
Detailed description
Lifestyle therapy is important for treating lifestyle-related morbidities such as obesity. Such therapy often includes exercise and nutrition, and leads to improved health, functionality and quality of life. Unfortunately, obesity leads to adverse changes in the physiological milieu, including inflammation and altered nutritional status such as reduced omega-3:omega-6 ratios. Indeed, inadequate omega 3 levels are common even among lean individuals. This may negatively affect the outcome of lifestyle therapy with exercise, particularly those involving resistance training, contributing to the large heterogeneity seen in training responses. In accordance with this, many individuals (including both lean and obese subjects) fail to improve muscle biology/functions and health, including failure to increase muscle mass and strength, failure to improve glucose handling and inflammatory status. This makes general lifestyle therapy recommendations ineffective. Here, we investigate effects of double-blinded, randomized placebo-controlled n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of low- and high-load resistance training on muscle growth/function/biology and health in individuals with obesity (BMI>30, n=60) and lean controls (BMI<30, n=60). Each participant will perform two different training protocols, one on each leg. The supplement period will commence 7 weeks prior to the onset of the strength training intervention to ensure adequate omega-3 biology at the onset of training. Analyses include assessment of the separate and combined effects of n3-supplementation and obesity on training responses to resistance training, measured as muscle mass, muscle strength/functionality, muscle biological traits, and systemic health variables such as hormone/inflammation/glucose biology, adipose tissue biology/mass, gut microbiome and health-related quality of life. The project will provide important insight into the feasibility of resistance training and n-3 fatty acid supplementation for treating individuals with obesity, paving the way for personalized lifestyle therapy.
The study has two defined main outcome measures, targeting the combined effects of omega-3 and strength training on i) muscle thickness of the thigh (measured using ultrasound; this main outcome measure targets the effects of the intervention on muscle growth), and ii) glucose tolerance (measured using an oral glucose test; this main outcome measure targets the effects of the intervention on improvements in health).
In our analytical approach, we will use a mixed model-approach to assess the main effects of the intervention, mainly defined as changes from before to after the resistance training intervention. Importantly, for health variables such as glucose tolerance, analyses will be performed by accounting for individual variation at baseline, as any beneficial effect can be expected to be higher/present only in individuals with a pathological/diseased starting point. Notably, for many variables, we will collect data from two additional time points (pre-supplementation and after two weeks of familiarization to training). These data will provide insight into additional perspectives, such as the effects of omega-3 intake-only on glucose tolerance, which will bring additional depth to our conclusions (these analyses are not necessarily specified in the Outcome Measures section). For other data, such as primary cultivation of skeletal muscle and muscle mitochondrial respiration, data will only be collected from a randomized subset of participants. For analyses of the effects of the intervention on obesity-related pathophysiologies and health-related quality of life, data from a group of non-intervention individuals will act as reference values (data sampled alongside the intervention). Finally, we will use regression analyses to explain individual differences in training responses, with particular emphasis on muscle hypertrophy/glucose tolerance and their mechanistic origin of nature.
2021/08: The number of anticipated participants was increased from 120 to 150 due to circumstances relating to the SARS-CoV-2 pandemic
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omega 3 | Experimental | Other: Resistance exercise, Dietary Supplement: Omega-3Intake of 1 gram omega-3 (capsules) per day for 20 weeks + high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training) |
| Placebo | Placebo comparator | Other: Resistance exercise, Dietary Supplement: PlaceboIntake of 1 gram sunflower oleic oil (capsules) per day for 20 weeks + high-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training) |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Untrained (less than 2 sessions of resistance exercise per month and less than 3 hours of endurance exercise per week)
Key exclusion criteria (6 listed)
- Unstable cardiovascular disease
- Injuries affecting the ability to perform heavy resistance exercise
- Mental illness
- Allergy to local anesthesia
- Smoking
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 |
|---|---|---|
| Resistance exerciseHigh-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training) | Other | Omega 3, Placebo |
| Omega-3Also: N-3 PUFA1 gram of omega-3 per day for 20 weeks | Dietary supplement | Omega 3 |
| Placebo1 gram of sunflower oleic oil per day for 20 weeks | Dietary supplement | Placebo |
Primary outcome
Muscle thickness, ultrasound
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle thickness of vastus lateralis and vastus intermedius measured using ultrasound
Glucose tolerance
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Glucose tolerance measured using an oral glucose tolerance test
48 secondary outcomes
Lean body mass
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Fat mass
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Visceral fat mass
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, MRI
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, immunohistochemistry
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle mass, combined measure
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle fibre type composition
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Myonuclear number
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle satellite cell number
Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Muscle capillarization
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Fat infiltration (muscle)
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Muscle quality
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Unilateral lower body maximal strength
Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Unilateral lower body isokinetic muscle strength
Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Unilateral lower body isometric muscle strength
Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Peak power output during one-legged cycling
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Oxygen consumption during one-legged cycling
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Unilateral lower body muscle endurance
Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
Waist circumference
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Blood pressure at rest
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Hemoglobin glycosylation (HbA1c)
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Fasting blood glucose
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
N-3 PUFA (blood)
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Inflammatory characteristics of peripheral blood mononuclear cell (PBMC)
Time frame: Throughout the course of the intervention (weeks 0, 8 and 20)
Lipid concentrations in blood
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Nutritent concentrations in blood
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Hormone concentrations in blood
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Concentrations of inflammatory factors in blood
Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)
Muscle fractional synthesis rate
Time frame: Week 18 to 20
Gene expression in skeletal muscle (intervention)
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Gene expression in skeletal muscle (familiarization)
Time frame: Changes from before to after familiarization to resistance exercise (week 8 to 10)
Protein abundance in skeletal muscle (intervention)
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Protein abundance in skeletal muscle (familiarization)
Time frame: Changes from before to after the resistance training intervention (week 8 to 10)
Mitochondrial functions in muscle
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Gene expression in subcutaneous fat
Time frame: Changes from before to after the resistance training intervention (week 8 to 20)
Satellite cell proliferation and myotube growth (in vitro)
Time frame: Changes from before to after N3-supplementation-only (week 0 to 8)
Musculoskeletal pain (Nordic Pain Questionnaire)
Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Musculoskeletal pain (VAS)
Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Gastrointestinal symptoms
Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
Gut microbiome (feces, N3-supplementation-only)
Time frame: Changes from before to after N3-supplementation-only (week 0 to 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
Stian Ellefsen, PhD principal investigator
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise and Omega-3 in people with Obesity, run by Inland Norway University of Applied Sciences at 1 site in Norway.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Aug 2022. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Muscle thickness, ultrasound (time frame: Changes from before to after the resistance training intervention (week 8 to 20)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.