NCT04545190

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

August 24, 2020

Last Update Submit

February 3, 2021

Conditions

Keywords

Strength/resistance trainingGlucose supplementationSkeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Total RNA in muscle tissue

    Total RNA content in m. vastus lateralis (ug per mg tissue)

    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

    Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)

  • Protein in skeletal muscle

    Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)

  • Gene expression in skeletal muscle

    Before the intervention and immediately after the intervention (i.e. after 5 training sessions of each leg)

  • Muscle fractional synthesis rate

    Immediately after the intervention

  • Glucose in blood, after glucose/placebo intake

    Immediately before glucose/placebo intake and 30 min, 45 min, 60 min and 195 min after initial glucose/placebo intake

  • +9 more secondary outcomes

Other Outcomes (7)

  • Training diary

    During each training session of the intervention

  • Body mass composition

    Prior to the intervention

  • Dietary registration

    During each day of the intervention

  • +4 more other outcomes

Study Arms (2)

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)

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)

Dietary Supplement: Glucose

Interventions

GlucoseDIETARY_SUPPLEMENT

To investigate the effects of glucose intake during resistance training on muscle biological adaptations

GlucosePlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking
  • Moderately trained (i.e. having performed 2-8 resistance training sessions per 14 days for the last six months)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, Norway

Location

Related Publications (1)

  • 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.

    PMID: 31813190BACKGROUND

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Stian Ellefsen, PhD

    Inland Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
On each intervention day, participants will receive boluses of supplements in accordance with his or her study ID number. The list that links this ID number to the randomization code will be kept with the person who generated the randomization code (and stored on a safe server) until completion of data sampling and cleaning of data on main outcome measures. The person resonsible for generating the randomization code will not be involved in any aspects of data sampling or handling. None of the project collaborators/participants will have access to this list during the intervention or during data handling. Half the participants (n=10) will commence the intervention with GLU on Day 1, while the other half will commence with PLAC (randomized). For participants starting with GLU, half will perform training on their dominant leg, while the other half will perform training on their non-dominant leg. The same will be the case for participants starting with PLAC.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

August 24, 2020

First Posted

September 10, 2020

Study Start

September 1, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations