Carbohydrate MetabolismNCT06400836
Nutrient Timing in Connection to Evening Exercise
A study testing Carbohydrate timing - carbohydrate intake before or after exercise in people with Carbohydrate Metabolism and Lipid Metabolism, run by Göteborg University at 1 site in Sweden.
Trial summary
Physical exercise (PE) significantly influences insulin sensitivity (IS), glucose control and overall metabolic health. While PE effectively enhances IS and glucose regulation, the timing of nutrient intake, before and after exercise, plays a crucial role in modulating its effects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Metabolism, Lipid Metabolism, Blood Glucose
- What is being tested?
- Carbohydrate timing - carbohydrate intake before or after exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2022to 2 Sep 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females and males
- 18-50 years
- Endurance fitness level of ≥40 mL O2/kg/min.
- Signed informed consent
Who cannot join
- Medical treatment and/or nutritional supplements that may affect glucose tolerance, substrate oxidation and performance capacity
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Food and Nutrition, and Sport Science, Centre for Health and Performance, University of Gothenburg, Gothenburg, Sweden
Gothenburg, Bohuslän, 405 30
About this study
Official title: Impact of Carbohydrate Timing on Glucose Metabolism and Substrate Oxidation Following High-Intensity Evening Aerobic Exercise in Athletes: A Randomized Controlled Study
Physical exercise (PE) significantly influences insulin sensitivity (IS), glucose control and overall metabolic health. While PE effectively enhances IS and glucose regulation, the timing of nutrient intake, before and after exercise, plays a crucial role in modulating its effects.
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate (CHO) ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test (OGTT).
Read the detailed description
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate (CHO) ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test (OGTT).
The primary objective is to assess glucose regulation during a 120-minute OGTT the following day.
The secondary objective is to investigate substrate metabolism (CHO and fat oxidation) during a 120-minute OGTT the following day.
Ten healthy, well-trained male endurance cyclists/triathletes, aged 19-45 years, are recruited via local contacts from the Gothenburg region, Sweden. The study is performed in accordance with the Declaration of Helsinki 2008 and is approved by the Swedish Ethical Review Authority (Dnr: 2022-03056-01). All participants gave their written informed consent before inclusion.
The study has a double-blind, randomized, placebo-controlled, crossover design.
After baseline assessment and determination of maximal oxygen uptake (VO2 max), participants undergo a familiarization cycle exercise trial. This trial serves a dual purpose: first, to establish the appropriate amount of CHO to be incorporated into the pre- or post-drink for subsequent cycle experimental trials, and second, to familiarize participants with the equipment and study protocol.
Three days prior to the cycle experimental trial, subcutaneous insertion of a glucose sensor for continuous glucose monitoring (CGM) takes place. Participants are randomly assigned to consume either a CHO drink or a placebo (PLA) drink (containing no energy) two hours prior to the cycle experimental trial that starts at 19:30. During the exercise trial, participants engage in submaximal cycling exercise at 70% of their maximal workload (Wmax), followed by a 25-minute time trial (TT). The total duration of the exercise session is approximately 90 minutes. Workload during the TT is individualized based on each participant's maximal work capacity (Wmax). During exercise, capillary glucose levels, heart rate, and rate of perceived exertion (RPE; Borg category scale 6-20) are measured. Additionally, respiratory gases are collected during 5-minute periods at every 15-minute interval to assess substrate utilization.
Immediately after completing the TT, participants switch to the opposite drink condition: those who initially received the CHO drink consume the PLA drink, and vice versa. The amount of CHO in the CHO drink consumed by each participant is precisely matched to the amount of CHO that the participant oxidizes during the exercise trial.
After the ingestion of the CHO- or placebo drink, participants fast overnight. CGM technology is used to measure interstitial glucose values during the night.
At 08:00, participants consume a 300mL solution containing 75g glucose for a 120-min OGTT. Capillary blood samples are collected at baseline and every 15 minutes during the OGTT. Respiratory gases are collected to measure substrate oxidation. The same protocol is reproduced the following week, with the reverse order of the test drink intake.
Three days preceding both control and experimental trials, participants are provided with a standardized diet consisting of pre-packaged meals that match their daily energy and macronutrient needs to prevent energy deficiency.
- Being tested
- Carbohydrate timing - carbohydrate intake before or after exercise
- Keywords
- Athletes, Continuous glucose monitoring, Exercise, Metabolism, Nutrition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate timing - carbohydrate intake before or after exerciseOther
The study aims to investigate how pre- or post evening exercise carbohydrate ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period (21:00-06:00) and the morning after during an 120 minute oral glucose tolerance test (OGTT).
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate drink | Active comparator | All study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, doubleblind crossover fashion. The CHO drink and placebo products have similar appearance and taste. Receives: Other: Carbohydrate timing - carbohydrate intake before or after exercise |
| Placebo | Placebo comparator | All study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, double-blind crossover fashion. The CHO drink and placebo products have similar appearance and taste. Receives: Other: Carbohydrate timing - carbohydrate intake before or after exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate change in glucose tolerance during a 75g glucose, 120 min oral glucose tolerance test (OGTT)
To quantify participants' glucose tolerance, the change in plasma glucose levels (mmol/L) will be measured over a 120-minute period following the ingestion of a standardized 75g glucose solution during an OGTT.
Measured: Comparing the change in glucose tolerance during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise, with carbohydrates consumed either before or after exercise.
Secondary outcomes (1)
To investigate substrate oxidation during the oral glucose tolerance test (OGTT)
To quantify substrate oxidation rates (carbohydrate oxidation (g/minute) and fat oxidation (g/minute), the change in respiratory exchange ratios (RER) will be measured during the 120-minute OGTT period.
Measured: Comparing the change in substrate oxidation during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise with carbohydrates being consumed either before or after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start10 Jan 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate MetabolismStudies 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
- Crossover Assignment Randomised double-blind cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Sponsor
- Investigators
- Stefan Pettersson, Assoc. Prof., Principal investigator, Department of Food and Nutrition, and Sport Science, University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400836
- Sponsor's protocol ID
- Dnr: 2022-03056-01
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Carbohydrate Timing on Glucose Metabolism and Substrate Oxidation Following High-Intensity Evening Aerobic Exercise in Athletes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06400836
- Acronym / sponsor ID
- Dnr: 2022-03056-01
- Keywords
- Athletes, Continuous glucose monitoring, Exercise, Metabolism, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 6 May 2024 (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.
Physical exercise (PE) significantly influences insulin sensitivity (IS), glucose control and overall metabolic health. While PE effectively enhances IS and glucose regulation, the timing of nutrient intake, before and after exercise, plays a crucial role in modulating its effects.
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate (CHO) ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test (OGTT).
Detailed description
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate (CHO) ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test (OGTT).
The primary objective is to assess glucose regulation during a 120-minute OGTT the following day.
The secondary objective is to investigate substrate metabolism (CHO and fat oxidation) during a 120-minute OGTT the following day.
Ten healthy, well-trained male endurance cyclists/triathletes, aged 19-45 years, are recruited via local contacts from the Gothenburg region, Sweden. The study is performed in accordance with the Declaration of Helsinki 2008 and is approved by the Swedish Ethical Review Authority (Dnr: 2022-03056-01). All participants gave their written informed consent before inclusion.
The study has a double-blind, randomized, placebo-controlled, crossover design.
After baseline assessment and determination of maximal oxygen uptake (VO2 max), participants undergo a familiarization cycle exercise trial. This trial serves a dual purpose: first, to establish the appropriate amount of CHO to be incorporated into the pre- or post-drink for subsequent cycle experimental trials, and second, to familiarize participants with the equipment and study protocol.
Three days prior to the cycle experimental trial, subcutaneous insertion of a glucose sensor for continuous glucose monitoring (CGM) takes place. Participants are randomly assigned to consume either a CHO drink or a placebo (PLA) drink (containing no energy) two hours prior to the cycle experimental trial that starts at 19:30. During the exercise trial, participants engage in submaximal cycling exercise at 70% of their maximal workload (Wmax), followed by a 25-minute time trial (TT). The total duration of the exercise session is approximately 90 minutes. Workload during the TT is individualized based on each participant's maximal work capacity (Wmax). During exercise, capillary glucose levels, heart rate, and rate of perceived exertion (RPE; Borg category scale 6-20) are measured. Additionally, respiratory gases are collected during 5-minute periods at every 15-minute interval to assess substrate utilization.
Immediately after completing the TT, participants switch to the opposite drink condition: those who initially received the CHO drink consume the PLA drink, and vice versa. The amount of CHO in the CHO drink consumed by each participant is precisely matched to the amount of CHO that the participant oxidizes during the exercise trial.
After the ingestion of the CHO- or placebo drink, participants fast overnight. CGM technology is used to measure interstitial glucose values during the night.
At 08:00, participants consume a 300mL solution containing 75g glucose for a 120-min OGTT. Capillary blood samples are collected at baseline and every 15 minutes during the OGTT. Respiratory gases are collected to measure substrate oxidation. The same protocol is reproduced the following week, with the reverse order of the test drink intake.
Three days preceding both control and experimental trials, participants are provided with a standardized diet consisting of pre-packaged meals that match their daily energy and macronutrient needs to prevent energy deficiency.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment Randomised double-blind cross-over study
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate drink | Active comparator | Other: Carbohydrate timing - carbohydrate intake before or after exerciseAll study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, doubleblind crossover fashion. The CHO drink and placebo products have similar appearance and taste. |
| Placebo | Placebo comparator | Other: Carbohydrate timing - carbohydrate intake before or after exerciseAll study participants will receive the carbohydrate (CHO) drink and the placebo in a randomized, double-blind crossover fashion. The CHO drink and placebo products have similar appearance and taste. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females and males
- 18-50 years
- Endurance fitness level of ≥40 mL O2/kg/min.
- Signed informed consent
Key exclusion criteria (1 listed)
- Medical treatment and/or nutritional supplements that may affect glucose tolerance, substrate oxidation and performance capacity
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 |
|---|---|---|
| Carbohydrate timing - carbohydrate intake before or after exerciseThe study aims to investigate how pre- or post evening exercise carbohydrate ingestion influences glucose metabolism and substrate oxidation (fat/CHO) during exercise and after exercise in athletes during the nocturnal period (21:00-06:00) and the morning after during an 120 minute oral glucose tolerance test (OGTT). | Other | Carbohydrate drink, Placebo |
Primary outcome
To investigate change in glucose tolerance during a 75g glucose, 120 min oral glucose tolerance test (OGTT)
Time frame: Comparing the change in glucose tolerance during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise, with carbohydrates consumed either before or after exercise.
To quantify participants' glucose tolerance, the change in plasma glucose levels (mmol/L) will be measured over a 120-minute period following the ingestion of a standardized 75g glucose solution during an OGTT.
1 secondary outcome
To investigate substrate oxidation during the oral glucose tolerance test (OGTT)
Time frame: Comparing the change in substrate oxidation during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise with carbohydrates being consumed either before or after exercise.
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 6 May 2024.
- 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.
Stefan Pettersson, Assoc. Prof. principal investigator
Department of Food and Nutrition, and Sport Science, University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate timing - carbohydrate intake before or after exercise in people with Carbohydrate Metabolism and Lipid Metabolism, run by Göteborg University at 1 site in Sweden.
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 4 inclusion and 1 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 6 May 2024. 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 Sweden. 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?
To investigate change in glucose tolerance during a 75g glucose, 120 min oral glucose tolerance test (OGTT) (time frame: Comparing the change in glucose tolerance during the OGTT between baseline (no exercise) week 0, compared to interventions week 1 and week 2 involving previous evening exercise, with carbohydrates consumed either before or after exercise.). 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 6 May 2024.