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NCT Number: NCT04279951

Alpha and Omega of Lifestyle Therapy

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inland Norway University of Applied Sciences

Lillehammer, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Untrained (less than 2 sessions of resistance exercise per month and less than 3 hours of endurance exercise per week)

Exclusion criteria

  • 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

Treatment and study plan

Resistance Exercise

Other

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-3

Dietary Supplement

1 gram of omega-3 per day for 20 weeks

Other names: N-3 PUFA

Placebo

Dietary Supplement

1 gram of sunflower oleic oil per day for 20 weeks

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Lean body mass

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Lean body mass measured using whole-body DXA scan

  2. Fat mass

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Fat mass measured using whole-body DXA scan

  3. Visceral fat mass

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Visceral fat mass measured using whole-body DXA scan

  4. Muscle mass, MRI

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Thigh muscle cross sectional area/volume measured using magnetic resonance imaging (MRI)

  5. Muscle mass, immunohistochemistry

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Fibre type-specific muscle-fibre cross-sectional area measured using immunohistochemistry

  6. Muscle mass, combined measure

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Muscle mass of the legs measured as the weighted average of data from ultrasound, MRI, immunohistochemistry and DXA measurements

  7. Muscle fibre type composition

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Muscle fibre type composition measured using immunohistochemistry

  8. Myonuclear number

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Fiber type-specific myonuclear number measured using immunohistochemistry

  9. Muscle satellite cell number

    Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)

    Fiber type-specific muscle satellite cell number measured using immunohistochemistry

  10. Muscle capillarization

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Fiber type-specific muscle capillarization measured using immunohistochemistry

  11. Fat infiltration (muscle)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Fat infiltration in thigh muscle measured using magnetic resonance imaging (MRI)

  12. Muscle quality

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Muscle strength measured per muscle mass of the legs

  13. Unilateral lower body maximal strength

    Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)

    The ability of muscles of the lower body to exert maximal force during dynamic movements

  14. Unilateral lower body isokinetic muscle strength

    Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)

    The ability of the knee extensors to exert maximal force during isokinetic movements

  15. Unilateral lower body isometric muscle strength

    Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)

    The ability of the knee extensors to exert maximal force during isometric actions

  16. Peak power output during one-legged cycling

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Maximal cycling performance measured as peak power output (Watt) during an incremental one-legged cycling test

  17. Oxygen consumption during one-legged cycling

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    The ability to consume oxygen during an incremental one-legged cycling test

  18. Unilateral lower body muscle endurance

    Time frame: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)

    The ability of muscles of the lower body to perform repeated dynamic contractions at a specified submaximal load (70% of 1RM) to exhaustion

  19. Waist circumference

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Circumference of the waist measured using measuring tape

  20. Blood pressure at rest

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Blood pressure at rest measured using an automated upper-arm blood pressure cuff

  21. Hemoglobin glycosylation (HbA1c)

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    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

  22. Fasting blood glucose

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Fasting blood glucose measured in serum

  23. N-3 PUFA (blood)

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Omega-3 (DHA/EPA) levels in blood

  24. Inflammatory characteristics of peripheral blood mononuclear cell (PBMC)

    Time frame: Throughout the course of the intervention (weeks 0, 8 and 20)

    Expression of genes associated with inflammation and lipid metabolism in peripheral blood mononuclear cell measured using quantitative PCR

  25. Lipid concentrations in blood

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Concentrations of various lipids and lipid metabolites such as triglycerides, LDL, HDL, ceramides, dihydroceramides, glucosylceramides, and lactosylceramides measured in serum using tageted metabolomics

  26. Nutritent concentrations in blood

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Concentrations of nutrients (such as amino acids) and ions (such as iron and calcium) measured in serum

  27. Hormone concentrations in blood

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Concentrations of hormones such as testosterone, growth hormone, thyroid hormones, cortisol and insulin (as well as c-peptide) measured in serum

  28. Concentrations of inflammatory factors in blood

    Time frame: Changes throughout the course of the intervention (weeks 0, 8 and 20)

    Levels of inflammatory factors such as IL6, CRP and NFkB in serum

  29. Muscle fractional synthesis rate

    Time frame: Week 18 to 20

    Protein/RNA synthesis rate measured using heavy water (deuterium) and chromatography/spectrometry

  30. Gene expression in skeletal muscle (intervention)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    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

  31. Gene expression in skeletal muscle (familiarization)

    Time frame: Changes from before to after familiarization to resistance exercise (week 8 to 10)

    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

  32. Protein abundance in skeletal muscle (intervention)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    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

  33. Protein abundance in skeletal muscle (familiarization)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 10)

    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

  34. Mitochondrial functions in muscle

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    The ability of muscle mitochondria (extracted from muscle homogenate) to synthesize ATP in vitro

  35. Gene expression in subcutaneous fat

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in subcutaneous fat, measured as targeted genes

  36. Satellite cell proliferation and myotube growth (in vitro)

    Time frame: Changes from before to after N3-supplementation-only (week 0 to 8)

    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

  37. Musculoskeletal pain (Nordic Pain Questionnaire)

    Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)

    Musculoskeletal pain measured using The standardized Nordic Pain Questionnaire

  38. Musculoskeletal pain (VAS)

    Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)

    Musculoskeletal pain measured using VAS-scale (1-10)

  39. Gastrointestinal symptoms

    Time frame: Changes throughout the course of the training intervention (weeks 0, 8 and 20)

    Gastrointestinal symptoms such as abdominal discomfort and pain, measured using Rome IV criteria

  40. Gut microbiome (feces, N3-supplementation-only)

    Time frame: Changes from before to after N3-supplementation-only (week 0 to 8)

    Relative composition of the gut microbiome measured using quantitative polymerase chain reaction

  41. Gut microbiome (feces, training intervention)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Relative composition of the gut microbiome measured using quantitative polymerase chain reaction

  42. Fecal short-chained fatty acids (N3-supplementation-only)

    Time frame: Changes from before to after N3-supplementation-only (week 0 to 8)

    Short chained fatty acids measured in feces

  43. Fecal short-chained fatty acids (training intervention)

    Time frame: Changes from before to after the resistance training intervention (week 8 to 20)

    Short chained fatty acids measured in feces

  44. Arterial stiffness

    Time frame: Throughout the course of the intervention (week 0, 8 and 20)

    Arterial stiffness measured using pulse-wave velocity

  45. Health-related quality of life (SF-36)

    Time frame: Changes throughout the course of the intervention (week 0, 8 and 20)

    Health-related quality of life measured using the SF-36 questionnaire

  46. Health-related quality of life in overweight/obesity

    Time frame: Changes throughout the course of the intervention (week 0, 8 and 20)

    Health-related quality of life in overweight/obesity individuals measured using The impact of weight on quality of life (IWQOL) questionnaire

  47. Health-related quality of life (PANAS)

    Time frame: Changes throughout the course of the intervention (week 0, 8 and 20)

    Health-related quality of life measured using the Positive and Negative Affect Schedule (PANAS) questionnaire

  48. Activities of daily living

    Time frame: Changes throughout the course of the intervention (week 0, 8 and 20)

    Activities of daily living (e.g. time spent in physical activity, intensities of activities) measured using questionnaire

Other outcomes

  1. Training diary relating to the intervention protocol

    Time frame: Weeks 8 to 20

    Information about intervention-specific training, including training frequency, volume and load

  2. Dietary registration

    Time frame: Week 0, 8 and 20

    Dietary registration measured using a food frequency questionnaire, assessing nutritional composition, energy intake and habitual patterns of dietary intake

Sponsors and collaborators

Lead sponsor

Inland Norway University of Applied Sciences

Other

Registry information

Official study 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

Acronym: Alpha&Omega

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Feb 21, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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