- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04279951
Alpha and Omega of Lifestyle Therapy (Alpha&Omega)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Lillehammer, Noruega
- Inland Norway University of Applied Sciences
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control
Sin intervención
|
|
Experimental: Omega 3
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) |
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)
1 gram of omega-3 per day for 20 weeks
Otros nombres:
|
Comparador de placebos: Placebo
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) |
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)
1 gram of sunflower oleic oil per day for 20 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Muscle thickness, ultrasound
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle thickness of vastus lateralis and vastus intermedius measured using ultrasound
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Glucose tolerance
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Glucose tolerance measured using an oral glucose tolerance test
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lean body mass
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Lean body mass measured using whole-body DXA scan
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Fat mass
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Fat mass measured using whole-body DXA scan
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Visceral fat mass
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Visceral fat mass measured using whole-body DXA scan
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle mass, MRI
Periodo de tiempo: 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)
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle mass, immunohistochemistry
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Fibre type-specific muscle-fibre cross-sectional area measured using immunohistochemistry
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle mass, combined measure
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle fibre type composition
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle fibre type composition measured using immunohistochemistry
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Myonuclear number
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Fiber type-specific myonuclear number measured using immunohistochemistry
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle satellite cell number
Periodo de tiempo: Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Fiber type-specific muscle satellite cell number measured using immunohistochemistry
|
Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Muscle capillarization
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Fiber type-specific muscle capillarization measured using immunohistochemistry
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Fat infiltration (muscle)
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Fat infiltration in thigh muscle measured using magnetic resonance imaging (MRI)
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle quality
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Muscle strength measured per muscle mass of the legs
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Unilateral lower body maximal strength
Periodo de tiempo: 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
|
Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Unilateral lower body isokinetic muscle strength
Periodo de tiempo: 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
|
Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Unilateral lower body isometric muscle strength
Periodo de tiempo: 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
|
Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Peak power output during one-legged cycling
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Oxygen consumption during one-legged cycling
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Unilateral lower body muscle endurance
Periodo de tiempo: 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
|
Changes throughout the course of the resistance training intervention (weeks 8, 10 and 20)
|
Waist circumference
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Circumference of the waist measured using measuring tape
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Blood pressure at rest
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Hemoglobin glycosylation (HbA1c)
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Fasting blood glucose
Periodo de tiempo: Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Fasting blood glucose measured in serum
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
N-3 PUFA (blood)
Periodo de tiempo: Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Omega-3 (DHA/EPA) levels in blood
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Inflammatory characteristics of peripheral blood mononuclear cell (PBMC)
Periodo de tiempo: 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
|
Throughout the course of the intervention (weeks 0, 8 and 20)
|
Lipid concentrations in blood
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Nutritent concentrations in blood
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Hormone concentrations in blood
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Concentrations of inflammatory factors in blood
Periodo de tiempo: Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Levels of inflammatory factors such as IL6, CRP and NFkB in serum
|
Changes throughout the course of the intervention (weeks 0, 8 and 20)
|
Muscle fractional synthesis rate
Periodo de tiempo: Week 18 to 20
|
Protein/RNA synthesis rate measured using heavy water (deuterium) and chromatography/spectrometry
|
Week 18 to 20
|
Gene expression in skeletal muscle (intervention)
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Gene expression in skeletal muscle (familiarization)
Periodo de tiempo: 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
|
Changes from before to after familiarization to resistance exercise (week 8 to 10)
|
Protein abundance in skeletal muscle (intervention)
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Protein abundance in skeletal muscle (familiarization)
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 10)
|
Mitochondrial functions in muscle
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Gene expression in subcutaneous fat
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Satellite cell proliferation and myotube growth (in vitro)
Periodo de tiempo: 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
|
Changes from before to after N3-supplementation-only (week 0 to 8)
|
Musculoskeletal pain (Nordic Pain Questionnaire)
Periodo de tiempo: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
|
Musculoskeletal pain measured using The standardized Nordic Pain Questionnaire
|
Changes throughout the course of the training intervention (weeks 0, 8 and 20)
|
Musculoskeletal pain (VAS)
Periodo de tiempo: Changes throughout the course of the training intervention (weeks 0, 8 and 20)
|
Musculoskeletal pain measured using VAS-scale (1-10)
|
Changes throughout the course of the training intervention (weeks 0, 8 and 20)
|
Gastrointestinal symptoms
Periodo de tiempo: 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
|
Changes throughout the course of the training intervention (weeks 0, 8 and 20)
|
Gut microbiome (feces, N3-supplementation-only)
Periodo de tiempo: Changes from before to after N3-supplementation-only (week 0 to 8)
|
Relative composition of the gut microbiome measured using quantitative polymerase chain reaction
|
Changes from before to after N3-supplementation-only (week 0 to 8)
|
Gut microbiome (feces, training intervention)
Periodo de tiempo: 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
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Fecal short-chained fatty acids (N3-supplementation-only)
Periodo de tiempo: Changes from before to after N3-supplementation-only (week 0 to 8)
|
Short chained fatty acids measured in feces
|
Changes from before to after N3-supplementation-only (week 0 to 8)
|
Fecal short-chained fatty acids (training intervention)
Periodo de tiempo: Changes from before to after the resistance training intervention (week 8 to 20)
|
Short chained fatty acids measured in feces
|
Changes from before to after the resistance training intervention (week 8 to 20)
|
Arterial stiffness
Periodo de tiempo: Throughout the course of the intervention (week 0, 8 and 20)
|
Arterial stiffness measured using pulse-wave velocity
|
Throughout the course of the intervention (week 0, 8 and 20)
|
Health-related quality of life (SF-36)
Periodo de tiempo: Changes throughout the course of the intervention (week 0, 8 and 20)
|
Health-related quality of life measured using the SF-36 questionnaire
|
Changes throughout the course of the intervention (week 0, 8 and 20)
|
Health-related quality of life in overweight/obesity
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (week 0, 8 and 20)
|
Health-related quality of life (PANAS)
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (week 0, 8 and 20)
|
Activities of daily living
Periodo de tiempo: 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
|
Changes throughout the course of the intervention (week 0, 8 and 20)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Training diary relating to the intervention protocol
Periodo de tiempo: Weeks 8 to 20
|
Information about intervention-specific training, including training frequency, volume and load
|
Weeks 8 to 20
|
Dietary registration
Periodo de tiempo: Week 0, 8 and 20
|
Dietary registration measured using a food frequency questionnaire, assessing nutritional composition, energy intake and habitual patterns of dietary intake
|
Week 0, 8 and 20
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stian Ellefsen, PhD, Inland Norway University of Applied Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Trainome 2019#015
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .