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The goal of this clinical trial is to determine whether a ketone supplement with carbohydrates extends time to fatigue during cycling compared with a carbohydrate-only supplement in healthy, trained cyclists aged 18-55. The main questions it aims to answer are:
Is the time to fatigue increased with ketone supplementation and carbohydrates compared to carbohydrates alone? Will ketone supplementation with carbohydrates produce lower blood lactate concentrations compared to carbohydrates alone?
Participants will:
The significance of this study is to address gaps in the literature by investigating the combined effects of R-1,3-Butanediol and carbohydrate supplementation on cycling performance during steady-state exercise above the lactate threshold. Participants include:
Trained cyclists ages 18-55
The sample is drawn from the University of Oklahoma, local cycling events in Oklahoma, and local bicycle shops.
There will be a total of three visits, lasting approximately one hour and separated by at least 7 days. The protocol begins with a familiarization visit, during which participants complete a maximal graded exercise test. They are instructed to be at least 4 hours postabsorptive and not complete strenuous exercise within 24 hours of the initial visit, and each participant signs an informed consent form, fills out a POMS questionnaire, and exercise history questionnaire (PAR-Q). Participants' height and weight were recorded, and their bicycles will be connected to the cycling trainer or will use the Zwift One stationary bicycle. To determine VO2 max and lactate threshold, a continuous incremental cycling test will be performed. The test begins at 1 watt per kilogram of body weight and increases 0.5 watts per kilogram of body weight every 3 minutes until two of the following were reached: volitional fatigue, inability to maintain cadence within 10 rpm of their preferred cadence, maximal heart rate within 10 bpm of age-predicted max heart rate, or respiratory exchange ratio greater than 1.10 The intent is to provide insights into metabolic and performance responses beyond traditional exercise intensities. The findings could inform endurance athletes and coaches on nutritional strategies for sustaining performance during high-intensity efforts.The study aims to investigate the performance effects of a ketone supplement (R-1,3-Butanediol) with carbohydrate supplementation on cycling performance above the lactate threshold. It aims to determine whether time to fatigue will be affected and if blood lactate concentrations will decrease due to ketone supplementation. Hypotheses include:
Time to fatigue is increased with ketone supplementation and carbohydrates compared to carbohydrates alone.
Ketone supplementation with carbohydrates will produce lower blood lactate concentrations compared to carbohydrates alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone supplementation with carbohydrates | Experimental |
| |
| Carbohydrate supplement only | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone supplementation | Dietary Supplement | 30-gram carbohydrate beverage with 5 grams of R-1,3-Butanediol every 30 minutes of experimental visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to fatigue | Through study completion, an average of 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lactate | Through study completion, an average of 2 weeks. | |
| Blood Glucose | Through study completion, an average of 2 weeks. | |
| Beta-hydroxybutyrate levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Larson, Ph.D. | Contact | 405-325-5211 | rdlarson@ou.edu | |
| Cole Connell | Contact | 405-628-3525 | cole.a.connell@ou.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma | Norman | Oklahoma | 73019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28116349 | Background | Beltz NM, Gibson AL, Janot JM, Kravitz L, Mermier CM, Dalleck LC. Graded Exercise Testing Protocols for the Determination of VO2max: Historical Perspectives, Progress, and Future Considerations. J Sports Med (Hindawi Publ Corp). 2016;2016:3968393. doi: 10.1155/2016/3968393. Epub 2016 Dec 25. | |
| 32868580 | Background |
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
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| Carbohydrate | Dietary Supplement | 30-gram carbohydrate beverage with bitter flavoring |
|
|
Using a finger prick to obtain a drop of blood to measure beta-hydroxybutyrate levels in the blood. |
| Through study completion, an average of 2 weeks. |
| Dearlove DJ, Harrison OK, Hodson L, Jefferson A, Clarke K, Cox PJ. The Effect of Blood Ketone Concentration and Exercise Intensity on Exogenous Ketone Oxidation Rates in Athletes. Med Sci Sports Exerc. 2021 Mar 1;53(3):505-516. doi: 10.1249/MSS.0000000000002502. |
| 29109686 | Background | Leckey JJ, Ross ML, Quod M, Hawley JA, Burke LM. Ketone Diester Ingestion Impairs Time-Trial Performance in Professional Cyclists. Front Physiol. 2017 Oct 23;8:806. doi: 10.3389/fphys.2017.00806. eCollection 2017. |
| 30632425 | Background | Shaw DM, Merien F, Braakhuis A, Plews D, Laursen P, Dulson DK. The Effect of 1,3-Butanediol on Cycling Time-Trial Performance. Int J Sport Nutr Exerc Metab. 2019 Sep 1;29(5):466-473. doi: 10.1123/ijsnem.2018-0284. |
| 27475046 | Background | Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27. |