Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400836
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-04-11
Brief Title:
Nutrient Timing in Connection to Evening Exercise
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Impact of Carbohydrate Timing on Glucose Metabolism and Substrate Oxidation Following High-Intensity Evening Aerobic Exercise in Athletes A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate CHO ingestion influences glucose metabolism and substrate oxidation fatCHO during exercise and after exercise in athletes during the nocturnal period and the morning after during an oral glucose tolerance test OGTT
The aim of this study is to evaluate how pre- or post-evening exercise carbohydrate CHO ingestion influences glucose metabolism and substrate oxidation fatCHO 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 fatCHO 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 cycliststriathletes 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 1930 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 participants 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 0800 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
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 cycliststriathletes 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 1930 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 participants 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 0800 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None