HealthyRibOSENCT04545190
RibOSE - Glucose and Resistance Exercise Training
A study testing Glucose in people with Healthy, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
The aim of the study is to investigate the effects of ingesting glucose during five bouts of resistance exercise on muscle biological charateristics in m. vastus lateralis of moderately trained healthy individuals (20-45 years of age, n=20) Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 20 Dec 2020
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- Moderately trained (i.e. having performed 2-8 resistance training sessions per 14 days for the last six months)
Who cannot join
- Not able to understand Norwegian
- Unstable cardiovascular disease
- Illness or injury contradicting heavy strength training
- Disabling musculoskeletal disease
- Serious mental illness
- Allergy to local anaesthesia
- Impaired glucose tolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RibOSE - Effects of Glucose Ingestion During Resistance Exercise Training on Ribosomal Biogenesis in Skeletal Muscle
The aim of the study is to investigate the effects of ingesting glucose during five bouts of resistance exercise on muscle biological charateristics in m. vastus lateralis of moderately trained healthy individuals (20-45 years of age, n=20)
Read the detailed description
Muscular responses to resistance training vary extensively between humans, with many showing impaired growth. In such individuals, cellular plasticity is compromised, leading to reduced functional and health-beneficial outcomes of training. While this is likely due to a range of determinants, including epigenetic, genetic and physiological variables, recent studies suggest that it involves reduced ability to produce novel ribosomes in response to training. This eventually leads to less pronounced increases in protein synthesis, and thus decreased growth rates, and makes ribosomal content in muscle a potential proxy marker for training-associated muscle hypertrophy.
In a recent study, the investigators showed that increased resistance training volume was associated with more pronounced muscle growth, a trait that was associated with increased ribosomal biogenesis. Despite this, ~50 % of the participants did not exhibit true beneficial effects of increased training volume, which in turn coincided with reduced abilities to accumulate ribosomes. In such individuals, other means are likely necessary to circumvent the negative influence of genetic and epigenetic predispositions on muscle plasticity. Nutrient supplementation stand out as a potential therapy. However, at present, knowledge with regard to this perspective is limited to a selected few nutrients, with protein ingestion being the best studied potential adjuvant, for which adequate intake seems to be essential for achieving optimal muscle growth, potentially being interconnected with ribosomal synthesis. For other nutrients, such as glucose, little is know about their importance for muscle plasticity and ribosomal biogenesis.
In cell types such as cultivated kidney cells, exposure to high levels of glucose is an efficient mean to increase ribosomal biogenesis (and growth rates). This suggests that glucose is an important signaling molecule for increasing ribosomal production per se, perhaps acting as a ligand for signaling proteins or by acting to increase energy availability. In the human body (as opposed to cultured cells), glucose may also exert growth-stimulating effects by increasing insulin levels in blood. Overall, it thus seems plausible that glucose intake during resistance training may stimulate ribosomal biogenesis, in turn having beneficial effects for protein synthesis and muscle plasticity, perhaps acting in an additive manner to protein supplementation. At present, we do not know if this is the case, though studies have suggested that glucose ingestion during acute resistance training sessions may reduce training-induced muscle damage without affecting within-session work output (i.e. volume). This lack of knowledge is surprising given the long-standing appreciation of the beneficial effects of glucose intake for endurance performance, acting to delay muscular fatigue.
- Conditions
- Healthy
- Being tested
- Glucose
- Keywords
- Strength/resistance training, Glucose supplementation, Skeletal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDietary supplement
To investigate the effects of glucose intake during resistance training on muscle biological adaptations
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Active comparator | Glucose will be ingested at three time points during resistance training (RT): 30 min prior to RT (30 g glucose mixed with 300 ml sugar-free Fun light lemonade), immediately prior to RT (30 g, 300 ml), and immediately after completion of training (30 g, 300 ml).
Protein supplement will be ingested at two time points: 2 hours prior to RT (e.g. at 0700 hrs, 25 g) and immediately after completion of training (25 g).
Placebo will be ingested during the afternoon (i.e. not during training; between 1800 hrs and 1900 hrs): 3 x 100 mg Stevia powder mixed with 3 x 300 ml sugar-free Fun light lemonade.
(The dietary intervention spans from 2200 hrs on the evening prior to RT sessions to ~2.5 hrs after completion of RT. During this time frame, participants will ingest glucose and protein supplements only) Receives: Dietary Supplement: Glucose |
| Placebo | Placebo comparator | Placebo will be ingested at three time points during resistance training (RT): 30 min prior to RT (100 mg Stevia powder mixed with 300 ml sugar-free Fun light lemonade), immediately prior to RT (100 mg, 300 ml), and immediately after completion of training (100 mg, 300 ml).
Protein supplement will be ingested at two time points: 2 hours prior to RT (e.g. at 0700 hrs, 25 g) and immediately after completion of training (25 g).
Glucose will be ingested during the afternoon (i.e. not during training; between 1800 hrs and 1900 hrs): 3 x 30 g glucose mixed with 3 x 300 ml sugar-free Fun light lemonade.
(The dietary intervention spans from 2200 hrs on the evening prior to RT sessions to ~2.5 hrs after completion of RT. I.e.: during this period, participants will ingest placebo and protein supplements only) Receives: Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total RNA in muscle tissue
Total RNA content in m. vastus lateralis (ug per mg tissue)
Measured: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Secondary outcomes (14)
Ribosomal RNA in skeletal muscle
Abundances of ribosomal RNA species in m. vastus lateralis measured using qPCR
Measured: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Protein in skeletal muscle
Abundances of protein species in m. vastus lateralis measured using Western blotting (e.g. ECM proteins)
Measured: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Gene expression in skeletal muscle
Abundances of mRNA species in m. vastus lateralis measured using qPCR
Measured: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Muscle fractional synthesis rate
Protein synthesis rate measured using heavy water (deuterium) and chromatography/spectrometry
Measured: Immediately after the intervention
Glucose in blood, after glucose/placebo intake
Glucose concentrations in blood (area under the curve), measured before and after intake of glucose/placebo on the two final days of the intervention (one day = glucose; one day = placebo)
Measured: Immediately before glucose/placebo intake and 30 min, 45 min, 60 min and 195 min after initial glucose/placebo intake
Glucose in blood (after protein intake)
Glucose concentrations in blood (area under the curve), measured before and after intake of protein on the two final days of the intervention
Measured: Immediately before protein intake and 45 min and 90 min after protein intake
Hormone concentrations in blood (after glucose/placebo intake)
Abundances of insulin, c-peptide, testosterone, growth hormone, cortisol and inflammatory markers in blood (area under the curve), measured before and after intake of glucose/placebo on the two final days of the intervention (one day = glucose; one day = placebo)
Measured: Immediately before glucose/placebo intake and 30 min and 60 min after the initial glucose/placebo intake
Hormone concentrations in blood (after protein intake)
Abundances of insulin, c-peptide, testosterone, growth hormone, cortisol and inflammatory markers in blood, measured after intake of protein on the two final days of the intervention
Measured: Immediately before protein intake and 90 min after protein intake
Unilateral lower body isokinetic muscle strength (during the intervention)
The ability of the knee extensors to exert maximal force during isokinetic movements (recovery/strength), measured before the intervention and at three time points during the intervention (~24 hours after training sessions)
Measured: Before the intervention and after the second, fourth and sixth training session
Unilateral lower body isokinetic muscle strength (last days of the intervention)
The ability of the knee extensors to exert maximal force during isokinetic movements (recovery/strength), measured before and at three time points after the last two training sessions (one day = glucose; one day = placebo)
Measured: Before the last training session and 30 min, 120 min and 24 hours after the last training session
Unilateral lower body isometric muscle strength (during the intervention)
The ability of the knee extensors to exert maximal force during isometric actions (recovery/strength), measured before the intervention and at three time points during the intervention (~24 hours after training sessions)
Measured: Before the intervention and after the second, fourth and sixth training session
Unilateral lower body isometric muscle strength (last days of the intervention)
The ability of the knee extensors to exert maximal force during isometric actions (recovery/strength), measured before and at three time points after the last two training sessions (one day = glucose; one day = placebo)
Measured: Before the last training session and 30 min, 120 min and 24 hours after the last training session
Perceived muscle soreness (during the intervention)
Muscular soreness measured before the intervention and at three time points during the intervention (~24 hours after training sessions) using a VAS-scale from 0 to 10 (0 = no soreness; 10 = maximal soreness)
Measured: Before the intervention and 24 hours after each training session
Perceived feeling of the legs (during the intervention)
Feeling of the legs measured immediately after each training session using a 9-point scale (1 = very very good, 9 = very very heavy)
Measured: 30 min after each training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Sep 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- The study will be conducted as a 12-day placebo-controlled randomized clinical trial. Each day will consist of concomitant dietary intervention and resistance training. The dietary intervention consists of alternating days of ingesting glucose (GLU, 90 g) or placebo (PLAC) in connection with training. Likewise, training consists of alternating days of resistance training of the two legs (using identical training protocols), with Day 1 involving training of the first leg, Day 2 involving training of the second leg, Day 3 involving training of the first leg, etc. In this way, each of the two dietary interventions will be associated with training of one particular leg, allowing within-subject comparisons of the effects of GLU vs PLAC on muscle biology and recovery.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sofie Lofthus, Inland Norway University of Applied Sciences
- Investigators
- Stian Ellefsen, PhD, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545190
- Sponsor's protocol ID
- Trainome#024_2020
- Acronym
- RibOSE
- Status last verified
- Feb 2021
- First submitted
- 24 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammarstrom D, Ofsteng S, Koll L, Hanestadhaugen M, Hollan I, Apro W, Whist JE, Blomstrand E, Ronnestad BR, Ellefsen S. Benefits of higher resistance-training volume are related to ribosome biogenesis. J Physiol. 2020 Feb;598(3):543-565. doi: 10.1113/JP278455. Epub 2020 Jan 15.
PubMed 31813190
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RibOSE - Effects of Glucose Ingestion During Resistance Exercise Training on Ribosomal Biogenesis in Skeletal Muscle
- ClinicalTrials.gov ID
- NCT04545190
- Acronym / sponsor ID
- RibOSE / Trainome#024_2020
- Conditions
- Healthy
- Keywords
- Strength/resistance training, Glucose supplementation, Skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 10 Sep 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 aim of the study is to investigate the effects of ingesting glucose during five bouts of resistance exercise on muscle biological charateristics in m. vastus lateralis of moderately trained healthy individuals (20-45 years of age, n=20)
Detailed description
Muscular responses to resistance training vary extensively between humans, with many showing impaired growth. In such individuals, cellular plasticity is compromised, leading to reduced functional and health-beneficial outcomes of training. While this is likely due to a range of determinants, including epigenetic, genetic and physiological variables, recent studies suggest that it involves reduced ability to produce novel ribosomes in response to training. This eventually leads to less pronounced increases in protein synthesis, and thus decreased growth rates, and makes ribosomal content in muscle a potential proxy marker for training-associated muscle hypertrophy.
In a recent study, the investigators showed that increased resistance training volume was associated with more pronounced muscle growth, a trait that was associated with increased ribosomal biogenesis. Despite this, ~50 % of the participants did not exhibit true beneficial effects of increased training volume, which in turn coincided with reduced abilities to accumulate ribosomes. In such individuals, other means are likely necessary to circumvent the negative influence of genetic and epigenetic predispositions on muscle plasticity. Nutrient supplementation stand out as a potential therapy. However, at present, knowledge with regard to this perspective is limited to a selected few nutrients, with protein ingestion being the best studied potential adjuvant, for which adequate intake seems to be essential for achieving optimal muscle growth, potentially being interconnected with ribosomal synthesis. For other nutrients, such as glucose, little is know about their importance for muscle plasticity and ribosomal biogenesis.
In cell types such as cultivated kidney cells, exposure to high levels of glucose is an efficient mean to increase ribosomal biogenesis (and growth rates). This suggests that glucose is an important signaling molecule for increasing ribosomal production per se, perhaps acting as a ligand for signaling proteins or by acting to increase energy availability. In the human body (as opposed to cultured cells), glucose may also exert growth-stimulating effects by increasing insulin levels in blood. Overall, it thus seems plausible that glucose intake during resistance training may stimulate ribosomal biogenesis, in turn having beneficial effects for protein synthesis and muscle plasticity, perhaps acting in an additive manner to protein supplementation. At present, we do not know if this is the case, though studies have suggested that glucose ingestion during acute resistance training sessions may reduce training-induced muscle damage without affecting within-session work output (i.e. volume). This lack of knowledge is surprising given the long-standing appreciation of the beneficial effects of glucose intake for endurance performance, acting to delay muscular fatigue.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be conducted as a 12-day placebo-controlled randomized clinical trial. Each day will consist of concomitant dietary intervention and resistance training. The dietary intervention consists of alternating days of ingesting glucose (GLU, 90 g) or placebo (PLAC) in connection with training. Likewise, training consists of alternating days of resistance training of the two legs (using identical training protocols), with Day 1 involving training of the first leg, Day 2 involving training of the second leg, Day 3 involving training of the first leg, etc. In this way, each of the two dietary interventions will be associated with training of one particular leg, allowing within-subject comparisons of the effects of GLU vs PLAC on muscle biology and recovery.
| Arm | Type | Receives |
|---|---|---|
| Glucose | Active comparator | Dietary Supplement: GlucoseGlucose will be ingested at three time points during resistance training (RT): 30 min prior to RT (30 g glucose mixed with 300 ml sugar-free Fun light lemonade), immediately prior to RT (30 g, 300 ml), and immediately after completion of training (30 g, 300 ml). Protein supplement will be ingested at two time points: 2 hours prior to RT (e.g. at 0700 hrs, 25 g) and immediately after completion of training (25 g). Placebo will be ingested during the afternoon (i.e. not during training; between 1800 hrs and 1900 hrs): 3 x 100 mg Stevia powder mixed with 3 x 300 ml sugar-free Fun light lemonade. (The dietary intervention spans from 2200 hrs on the evening prior to RT sessions to ~2.5 hrs after completion of RT. During this time frame, participants will ingest glucose and protein supplements only) |
| Placebo | Placebo comparator | Dietary Supplement: GlucosePlacebo will be ingested at three time points during resistance training (RT): 30 min prior to RT (100 mg Stevia powder mixed with 300 ml sugar-free Fun light lemonade), immediately prior to RT (100 mg, 300 ml), and immediately after completion of training (100 mg, 300 ml). Protein supplement will be ingested at two time points: 2 hours prior to RT (e.g. at 0700 hrs, 25 g) and immediately after completion of training (25 g). Glucose will be ingested during the afternoon (i.e. not during training; between 1800 hrs and 1900 hrs): 3 x 30 g glucose mixed with 3 x 300 ml sugar-free Fun light lemonade. (The dietary intervention spans from 2200 hrs on the evening prior to RT sessions to ~2.5 hrs after completion of RT. I.e.: during this period, participants will ingest placebo and protein supplements only) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-smoking
- Moderately trained (i.e. having performed 2-8 resistance training sessions per 14 days for the last six months)
Key exclusion criteria (7 listed)
- Not able to understand Norwegian
- Unstable cardiovascular disease
- Illness or injury contradicting heavy strength training
- Disabling musculoskeletal disease
- Serious mental illness
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 |
|---|---|---|
| GlucoseTo investigate the effects of glucose intake during resistance training on muscle biological adaptations | Dietary supplement | Glucose, Placebo |
Primary outcome
Total RNA in muscle tissue
Time frame: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Total RNA content in m. vastus lateralis (ug per mg tissue)
14 secondary outcomes
Ribosomal RNA in skeletal muscle
Time frame: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Protein in skeletal muscle
Time frame: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Gene expression in skeletal muscle
Time frame: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)
Muscle fractional synthesis rate
Time frame: Immediately after the intervention
Glucose in blood, after glucose/placebo intake
Time frame: Immediately before glucose/placebo intake and 30 min, 45 min, 60 min and 195 min after initial glucose/placebo intake
Glucose in blood (after protein intake)
Time frame: Immediately before protein intake and 45 min and 90 min after protein intake
Hormone concentrations in blood (after glucose/placebo intake)
Time frame: Immediately before glucose/placebo intake and 30 min and 60 min after the initial glucose/placebo intake
Hormone concentrations in blood (after protein intake)
Time frame: Immediately before protein intake and 90 min after protein intake
Unilateral lower body isokinetic muscle strength (during the intervention)
Time frame: Before the intervention and after the second, fourth and sixth training session
Unilateral lower body isokinetic muscle strength (last days of the intervention)
Time frame: Before the last training session and 30 min, 120 min and 24 hours after the last training session
Unilateral lower body isometric muscle strength (during the intervention)
Time frame: Before the intervention and after the second, fourth and sixth training session
Unilateral lower body isometric muscle strength (last days of the intervention)
Time frame: Before the last training session and 30 min, 120 min and 24 hours after the last training session
Perceived muscle soreness (during the intervention)
Time frame: Before the intervention and 24 hours after each training session
Perceived feeling of the legs (during the intervention)
Time frame: 30 min after each training session
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 4 Feb 2021.
- Background: PubMed 31813190Hammarstrom D, Ofsteng S, Koll L, Hanestadhaugen M, Hollan I, Apro W, Whist JE, Blomstrand E, Ronnestad BR, Ellefsen S. Benefits of higher resistance-training volume are related to ribosome biogenesis. J Physiol. 2020 Feb;598(3):543-565. doi: 10.1113/JP278455. Epub 2020 Jan 15.
- Individual participant dataSharing planned: No
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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 Glucose in people with Healthy, 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 2 inclusion and 7 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 4 Feb 2021. 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?
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?
Total RNA in muscle tissue (time frame: Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)). 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 NCT04545190, which also lists 1 linked publication.
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 4 Feb 2021.