A Replicate Crossover Trial on Nutritional Supplementation in Association Football (Soccer)

NCT07190989 | Completed

• 1 other identifier: F202501089
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Problems of sleep disorders and disruption are common particularly in Arab populations, and sleep insufficiency hinders the pursuit of high performance and optimal recovery following training and competition. Adequate investigation and personalization of dietary interventions to enhance sleep and recovery requires employing suitable methods of experimentation that involves repeated administration of treatment and placebo conditions, following a replicate crossover trial design, for derivation of athlete by dietary treatment interaction to inform decisions of supplementation dosing personalization embedded into routine service provision. Nevertheless, no study in sports performance explored this and other issues following adequate methodology and research design requirements. Accordingly, the project seeks to investigate the main effects and whether inter-individual variability exists in free-living objective sleep and recovery responses to novel nutritional blend supplementation in the form of a mixed juice (15000 mg cherry juice concentrate, 220 mg cherry extract, 250 mg cocoa extract, 200 mg of tryptophan, 100 mg of L-5-Hydroxytryptophan, 3000 mg of glycine, 300 mg of magnesium, 200 mg of theanine) adopting a replicate crossover design.

Conditions

Healthy

Keywords

actigraphy; ergogenic dietary supplements; replicate crossover; individual variability

Outcome Measures

Primary Outcomes (1)

• Time asleep

  Time asleep, defined as 'the actual time that a person spends asleep excluding non-sleep-related activities in bed', tracked using actigraphy (ActiGraph GT9X Link monitors ) will represent the primary outcome measure in this investigation.

  From enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (6)

• Sleep onset latency

  From enrollment to the end of treatment at 4 weeks.

• Wake-after-sleep-onset

  From enrollment to the end of treatment at 4 weeks.

• Sleep efficiency

  From enrolment to 4 weeks

• Sleep diary

  From enrollment to the end of treatment at 4 weeks.

• Borg Ratings of perceived exertion (RPE) CR-100 scale (0-100)

  From enrollment to the end of treatment at 4 weeks.

Study Arms (2)

Supplementation

EXPERIMENTAL

In the absence of established target difference and design-specific variance values relevant to each primary outcome measure considered in this study, and in keeping with procedures adopted to sample size justification in previous research adopting a replicate crossover design (Gonzalez et al., 2024), a minimum sample size of 12 participants would translate to a one-tailed between-cycle correlation of 0.5, with a 90% confidence interval for this correlation ranging from 0.00 to 0.80, assuming a null and a negative correlation would suggest non-rejection of the null hypothesis (r ≤ 0). The treatment administration will involve a nutritional blend consisting of a mixed juice containing 15000 mg cherry juice concentrate, 220 mg cherry extract, 250 mg cocoa extract, 200 mg of tryptophan, 100 mg of L-5-Hydroxytryptophan, 3000 mg of glycine, 300 mg of magnesium, 200 mg of Theanine manufactured by Science in Sport (https://sport.wetestyoutrust.com/supplement-search/science-sport/rest-juice).

Dietary Supplement: Nutritional Supplement

Placebo

PLACEBO COMPARATOR

In the absence of established target difference and design-specific variance values relevant to each primary outcome measure considered in this study, and in keeping with procedures adopted to sample size justification in previous research adopting a replicate crossover design (Gonzalez et al., 2024), a minimum sample size of 12 participants would translate to a one-tailed between-cycle correlation of 0.5, with a 90% confidence interval for this correlation ranging from 0.00 to 0.80, assuming a null and a negative correlation would suggest non-rejection of the null hypothesis (r ≤ 0). The placebo treatment will involve a 40g dual-source carbohydrate gel, having a 1:0.8 ratio of maltodextrin and fructose, as an alternative supplementation known for having trivial effects on sleep-related outcome measures (https://sport.wetestyoutrust.com/supplement-search/science-sport/beta-fuel-dual-source-energy-gel-beta-fuel-maltodextrin-fructose).

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Nutritional Supplement DIETARY_SUPPLEMENT

A mixed juice containing 15000 mg cherry juice concentrate, 220 mg cherry extract, 250 mg cocoa extract, 200 mg of tryptophan, 100 mg of L-5-Hydroxytryptophan, 3000 mg of glycine, 300 mg of magnesium, 200 mg of theanine manufactured by Science in Sport (https://sport.wetestyoutrust.com/supplement-search/science-sport/rest-juice).

Supplementation

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

A 40g dual-source carbohydrate gel, having a 1:0.8 ratio of maltodextrin and fructose manufactured by Science in Sport (https://sport.wetestyoutrust.com/supplement-search/science-sport/beta-fuel-dual-source-energy-gel-beta-fuel-maltodextrin-fructose).

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aspire Academy student-athlete (football)
• Healthy student-athletes currently injury-free and fully available for training and competition

You may not qualify if:

• Any participant not enrolled as Aspire Academy student-athlete
• Any Aspire Academy student-athlete currently facing any kind of sports injury

Sponsors & Collaborators

• Aspire Academy: lead

Study Sites (1)

Aspire Academy, Football Performance and Science Department

Doha, Qatar

Location

Related Publications (57)

• Deng C, Graz JC. Generating randomization schedules using SAS® programming. In N.W. Galwey (Ed.), Proceedings of the twenty-seventh annual SAS users group international conference (pp. 267-327). 2002.

  BACKGROUND

• Senn S, Stevens L, Chaturvedi N. Repeated measures in clinical trials: simple strategies for analysis using summary measures. Stat Med. 2000 Mar 30;19(6):861-77. doi: 10.1002/(sici)1097-0258(20000330)19:63.0.co;2-f.

  PMID: 10734289 BACKGROUND

• Zucker DR, Schmid CH, McIntosh MW, D'Agostino RB, Selker HP, Lau J. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol. 1997 Apr;50(4):401-10. doi: 10.1016/s0895-4356(96)00429-5.

  PMID: 9179098 BACKGROUND

• Youngstedt SD. Ceiling and floor effects in sleep research. Sleep Med Rev. 2003 Aug;7(4):351-65. doi: 10.1053/smrv.2001.0239.

  PMID: 14505601 BACKGROUND

• Walsh NP, Halson SL, Sargent C, Roach GD, Nedelec M, Gupta L, Leeder J, Fullagar HH, Coutts AJ, Edwards BJ, Pullinger SA, Robertson CM, Burniston JG, Lastella M, Le Meur Y, Hausswirth C, Bender AM, Grandner MA, Samuels CH. Sleep and the athlete: narrative review and 2021 expert consensus recommendations. Br J Sports Med. 2020 Nov 3:bjsports-2020-102025. doi: 10.1136/bjsports-2020-102025. Online ahead of print.

  PMID: 33144349 BACKGROUND

• Viechtbauer W. Confidence intervals for the amount of heterogeneity in meta-analysis. Stat Med. 2007 Jan 15;26(1):37-52. doi: 10.1002/sim.2514.

  PMID: 16463355 BACKGROUND

• Veroniki AA, Jackson D, Viechtbauer W, Bender R, Bowden J, Knapp G, Kuss O, Higgins JP, Langan D, Salanti G. Methods to estimate the between-study variance and its uncertainty in meta-analysis. Res Synth Methods. 2016 Mar;7(1):55-79. doi: 10.1002/jrsm.1164. Epub 2015 Sep 2.

  PMID: 26332144 BACKGROUND

• Van Someren EJ, Cirelli C, Dijk DJ, Van Cauter E, Schwartz S, Chee MW. Disrupted Sleep: From Molecules to Cognition. J Neurosci. 2015 Oct 14;35(41):13889-95. doi: 10.1523/JNEUROSCI.2592-15.2015.

  PMID: 26468189 BACKGROUND

• Tudor-Locke C, Barreira TV, Schuna JM Jr, Mire EF, Katzmarzyk PT. Fully automated waist-worn accelerometer algorithm for detecting children's sleep-period time separate from 24-h physical activity or sedentary behaviors. Appl Physiol Nutr Metab. 2014 Jan;39(1):53-7. doi: 10.1139/apnm-2013-0173. Epub 2013 Jun 26.

  PMID: 24383507 BACKGROUND

• St-Onge MP, Mikic A, Pietrolungo CE. Effects of Diet on Sleep Quality. Adv Nutr. 2016 Sep 15;7(5):938-49. doi: 10.3945/an.116.012336. Print 2016 Sep.

  PMID: 27633109 BACKGROUND

• Short MA, Arora T, Gradisar M, Taheri S, Carskadon MA. How Many Sleep Diary Entries Are Needed to Reliably Estimate Adolescent Sleep? Sleep. 2017 Mar 1;40(3):zsx006. doi: 10.1093/sleep/zsx006.

  PMID: 28199718 BACKGROUND

• Shen T, Thackray AE, King JA, Alotaibi TF, Alanazi TM, Willis SA, Roberts MJ, Lolli L, Atkinson G, Stensel DJ. Are There Interindividual Responses of Cardiovascular Disease Risk Markers to Acute Exercise? A Replicate Crossover Trial. Med Sci Sports Exerc. 2024 Jan 1;56(1):63-72. doi: 10.1249/MSS.0000000000003283. Epub 2023 Aug 30.

  PMID: 37703030 BACKGROUND

• Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC, Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENT Group. CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and elaboration. BMJ. 2015 May 14;350:h1793. doi: 10.1136/bmj.h1793. No abstract available.

  PMID: 25976162 BACKGROUND

• Senn S. The analysis of continuous data from n-of-1 trials using paired cycles: a simple tutorial. Trials. 2024 Feb 16;25(1):128. doi: 10.1186/s13063-024-07964-7.

  PMID: 38365817 BACKGROUND

• Senn S. Sample size considerations for n-of-1 trials. Stat Methods Med Res. 2019 Feb;28(2):372-383. doi: 10.1177/0962280217726801. Epub 2017 Sep 7.

  PMID: 28882093 BACKGROUND

• Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016 Mar 30;35(7):966-77. doi: 10.1002/sim.6739. Epub 2015 Sep 28.

  PMID: 26415869 BACKGROUND

• Senn S. Suspended judgment n-of-1 trials. Control Clin Trials. 1993 Feb;14(1):1-5. doi: 10.1016/0197-2456(93)90045-f. No abstract available.

  PMID: 8440091 BACKGROUND

• Senn S, Rolfe K, Julious SA. Investigating variability in patient response to treatment--a case study from a replicate cross-over study. Stat Methods Med Res. 2011 Dec;20(6):657-66. doi: 10.1177/0962280210379174. Epub 2010 Aug 25.

  PMID: 20739334 BACKGROUND

• ROSE WC, WIXOM RL, LOCKHART HB, LAMBERT GF. The amino acid requirements of man. XV. The valine requirement; summary and final observations. J Biol Chem. 1955 Dec;217(2):987-95. No abstract available.

  PMID: 13271458 BACKGROUND

• Reed DL, Sacco WP. Measuring Sleep Efficiency: What Should the Denominator Be? J Clin Sleep Med. 2016 Feb;12(2):263-6. doi: 10.5664/jcsm.5498.

  PMID: 26194727 BACKGROUND

• Quante M, Kaplan ER, Cailler M, Rueschman M, Wang R, Weng J, Taveras EM, Redline S. Actigraphy-based sleep estimation in adolescents and adults: a comparison with polysomnography using two scoring algorithms. Nat Sci Sleep. 2018 Jan 18;10:13-20. doi: 10.2147/NSS.S151085. eCollection 2018.

  PMID: 29403321 BACKGROUND

• Nikles J, Mitchell GK, Schluter P, Good P, Hardy J, Rowett D, Shelby-James T, Vohra S, Currow D. Aggregating single patient (n-of-1) trials in populations where recruitment and retention was difficult: the case of palliative care. J Clin Epidemiol. 2011 May;64(5):471-80. doi: 10.1016/j.jclinepi.2010.05.009. Epub 2010 Oct 8.

  PMID: 20933365 BACKGROUND

• Mountjoy M, Sundgot-Borgen JK, Burke LM, Ackerman KE, Blauwet C, Constantini N, Lebrun C, Lundy B, Melin AK, Meyer NL, Sherman RT, Tenforde AS, Klungland Torstveit M, Budgett R. IOC consensus statement on relative energy deficiency in sport (RED-S): 2018 update. Br J Sports Med. 2018 Jun;52(11):687-697. doi: 10.1136/bjsports-2018-099193. No abstract available.

  PMID: 29773536 BACKGROUND

• Merry TL, Ristow M. Do antioxidant supplements interfere with skeletal muscle adaptation to exercise training? J Physiol. 2016 Sep 15;594(18):5135-47. doi: 10.1113/JP270654. Epub 2016 Jan 18.

  PMID: 26638792 BACKGROUND

• Maquet P. The role of sleep in learning and memory. Science. 2001 Nov 2;294(5544):1048-52. doi: 10.1126/science.1062856.

  PMID: 11691982 BACKGROUND

• Lyon MR, Kapoor MP, Juneja LR. The effects of L-theanine (Suntheanine(R)) on objective sleep quality in boys with attention deficit hyperactivity disorder (ADHD): a randomized, double-blind, placebo-controlled clinical trial. Altern Med Rev. 2011 Dec;16(4):348-54.

  PMID: 22214254 BACKGROUND

• Lolli L, Bonanno D, Lopez E, Di Salvo V. Night-to-night variability of objective sleep outcomes in youth Middle Eastern football players. Sleep Med. 2024 May;117:193-200. doi: 10.1016/j.sleep.2024.03.023. Epub 2024 Mar 19.

  PMID: 38564918 BACKGROUND

• Lolli L, Cardinale M, Lopez E, Maasar MF, Marthinussen J, Bonanno D, Gregson W, Di Salvo V. An objective description of routine sleep habits in elite youth football players from the Middle-East. Sleep Med. 2021 Apr;80:96-99. doi: 10.1016/j.sleep.2021.01.029. Epub 2021 Jan 23.

  PMID: 33588263 BACKGROUND

• Logan RW, McClung CA. Rhythms of life: circadian disruption and brain disorders across the lifespan. Nat Rev Neurosci. 2019 Jan;20(1):49-65. doi: 10.1038/s41583-018-0088-y.

  PMID: 30459365 BACKGROUND

• Langan-Evans C, Hearris MA, Gallagher C, Long S, Thomas C, Moss AD, Cheung W, Howatson G, Morton JP. Nutritional Modulation of Sleep Latency, Duration, and Efficiency: A Randomized, Repeated-Measures, Double-Blind Deception Study. Med Sci Sports Exerc. 2023 Feb 1;55(2):289-300. doi: 10.1249/MSS.0000000000003040. Epub 2022 Sep 9.

  PMID: 36094342 BACKGROUND

• Langan D, Higgins JPT, Jackson D, Bowden J, Veroniki AA, Kontopantelis E, Viechtbauer W, Simmonds M. A comparison of heterogeneity variance estimators in simulated random-effects meta-analyses. Res Synth Methods. 2019 Mar;10(1):83-98. doi: 10.1002/jrsm.1316. Epub 2018 Sep 6.

  PMID: 30067315 BACKGROUND

• Lakens D. Sample size justification. Collabra Psychol. 2022;8(1):33267.

  BACKGROUND

• Knutson KL, Rathouz PJ, Yan LL, Liu K, Lauderdale DS. Intra-individual daily and yearly variability in actigraphically recorded sleep measures: the CARDIA study. Sleep. 2007 Jun;30(6):793-6. doi: 10.1093/sleep/30.6.793.

  PMID: 17580601 BACKGROUND

• Johnston RD, Hewitt A, Duthie G. Validity of Real-Time Ultra-wideband Global Navigation Satellite System Data Generated by a Wearable Microtechnology Unit. J Strength Cond Res. 2020 Jul;34(7):2071-2075. doi: 10.1519/JSC.0000000000003059.

  PMID: 32598123 BACKGROUND

• IntHout J, Ioannidis JP, Rovers MM, Goeman JJ. Plea for routinely presenting prediction intervals in meta-analysis. BMJ Open. 2016 Jul 12;6(7):e010247. doi: 10.1136/bmjopen-2015-010247.

  PMID: 27406637 BACKGROUND

• IntHout J, Ioannidis JP, Borm GF. The Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis is straightforward and considerably outperforms the standard DerSimonian-Laird method. BMC Med Res Methodol. 2014 Feb 18;14:25. doi: 10.1186/1471-2288-14-25.

  PMID: 24548571 BACKGROUND

• Hannon MP, Parker LJF, Carney DJ, McKeown J, Speakman JR, Hambly C, Drust B, Unnithan VB, Close GL, Morton JP. Energy Requirements of Male Academy Soccer Players from the English Premier League. Med Sci Sports Exerc. 2021 Jan;53(1):200-210. doi: 10.1249/MSS.0000000000002443.

  PMID: 32701871 BACKGROUND

• Gonzalez JT, Lolli L, Veasey RC, Rumbold PLS, Betts JA, Atkinson G, Stevenson EJ. Are there interindividual differences in the reactive hypoglycaemia response to breakfast? A replicate crossover trial. Eur J Nutr. 2024 Dec;63(8):2897-2909. doi: 10.1007/s00394-024-03467-y. Epub 2024 Sep 4.

  PMID: 39231870 BACKGROUND

• Goltz FR, Thackray AE, Atkinson G, Lolli L, King JA, Dorling JL, Dowejko M, Mastana S, Stensel DJ. True Interindividual Variability Exists in Postprandial Appetite Responses in Healthy Men But Is Not Moderated by the FTO Genotype. J Nutr. 2019 Jul 1;149(7):1159-1169. doi: 10.1093/jn/nxz062.

  PMID: 31132105 BACKGROUND

• Goltz FR, Thackray AE, King JA, Dorling JL, Atkinson G, Stensel DJ. Interindividual Responses of Appetite to Acute Exercise: A Replicated Crossover Study. Med Sci Sports Exerc. 2018 Apr;50(4):758-768. doi: 10.1249/MSS.0000000000001504.

  PMID: 29240652 BACKGROUND

• Garlick PJ. The nature of human hazards associated with excessive intake of amino acids. J Nutr. 2004 Jun;134(6 Suppl):1633S-1639S; discussion 1664S-1666S, 1667S-1672S. doi: 10.1093/jn/134.6.1633S.

  PMID: 15173443 BACKGROUND

• Fox JL, Scanlan AT, Stanton R, Sargent C. Insufficient Sleep in Young Athletes? Causes, Consequences, and Potential Treatments. Sports Med. 2020 Mar;50(3):461-470. doi: 10.1007/s40279-019-01220-8.

  PMID: 31679145 BACKGROUND

• Fernstrom JD. Effects and side effects associated with the non-nutritional use of tryptophan by humans. J Nutr. 2012 Dec;142(12):2236S-2244S. doi: 10.3945/jn.111.157065. Epub 2012 Oct 17.

  PMID: 23077193 BACKGROUND

• Elango R. Tolerable Upper Intake Level for Individual Amino Acids in Humans: A Narrative Review of Recent Clinical Studies. Adv Nutr. 2023 Jul;14(4):885-894. doi: 10.1016/j.advnut.2023.04.004. Epub 2023 Apr 14.

  PMID: 37062432 BACKGROUND

• Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.

  PMID: 31366597 BACKGROUND

• Di Salvo V, Gregson W, Atkinson G, Tordoff P, Drust B. Analysis of high intensity activity in Premier League soccer. Int J Sports Med. 2009 Mar;30(3):205-12. doi: 10.1055/s-0028-1105950. Epub 2009 Feb 12.

  PMID: 19214939 BACKGROUND

• Coates S, Taubel J, Lorch U. Practical risk management in early phase clinical trials. Eur J Clin Pharmacol. 2019 Apr;75(4):483-496. doi: 10.1007/s00228-018-02607-8. Epub 2018 Dec 19.

  PMID: 30569285 BACKGROUND

• Cynober L, Bier DM, Kadowaki M, Morris SM Jr, Elango R, Smriga M. Proposals for Upper Limits of Safe Intake for Arginine and Tryptophan in Young Adults and an Upper Limit of Safe Intake for Leucine in the Elderly. J Nutr. 2016 Dec;146(12):2652S-2654S. doi: 10.3945/jn.115.228478. Epub 2016 Nov 9.

  PMID: 27934658 BACKGROUND

• de Zambotti M, Cellini N, Goldstone A, Colrain IM, Baker FC. Wearable Sleep Technology in Clinical and Research Settings. Med Sci Sports Exerc. 2019 Jul;51(7):1538-1557. doi: 10.1249/MSS.0000000000001947.

  PMID: 30789439 BACKGROUND

• Covassin N, Singh P, McCrady-Spitzer SK, St Louis EK, Calvin AD, Levine JA, Somers VK. Effects of Experimental Sleep Restriction on Energy Intake, Energy Expenditure, and Visceral Obesity. J Am Coll Cardiol. 2022 Apr 5;79(13):1254-1265. doi: 10.1016/j.jacc.2022.01.038.

  PMID: 35361348 BACKGROUND

• Chatters R, Hawksworth O, Julious S, Cook A. The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials. Trials. 2024 Jul 11;25(1):473. doi: 10.1186/s13063-024-08261-z.

  PMID: 38992786 BACKGROUND

• Bruni O, Ferri R, Miano S, Verrillo E. L -5-Hydroxytryptophan treatment of sleep terrors in children. Eur J Pediatr. 2004 Jul;163(7):402-7. doi: 10.1007/s00431-004-1444-7. Epub 2004 May 14.

  PMID: 15146330 BACKGROUND

• Borenstein M. Avoiding common mistakes in meta-analysis: Understanding the distinct roles of Q, I-squared, tau-squared, and the prediction interval in reporting heterogeneity. Res Synth Methods. 2024 Mar;15(2):354-368. doi: 10.1002/jrsm.1678. Epub 2023 Nov 8.

  PMID: 37940120 BACKGROUND

• Barrett JR, Tracy DK, Giaroli G. To sleep or not to sleep: a systematic review of the literature of pharmacological treatments of insomnia in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013 Dec;23(10):640-7. doi: 10.1089/cap.2013.0059. Epub 2013 Nov 21.

  PMID: 24261659 BACKGROUND

• Bacchetti P. Current sample size conventions: flaws, harms, and alternatives. BMC Med. 2010 Mar 22;8:17. doi: 10.1186/1741-7015-8-17.

  PMID: 20307281 BACKGROUND

• Atkinson G, Batterham AM. True and false interindividual differences in the physiological response to an intervention. Exp Physiol. 2015 Jun;100(6):577-88. doi: 10.1113/EP085070. Epub 2015 May 13.

  PMID: 25823596 BACKGROUND

• Atkinson G, Williamson P, Batterham AM. Issues in the determination of 'responders' and 'non-responders' in physiological research. Exp Physiol. 2019 Aug;104(8):1215-1225. doi: 10.1113/EP087712. Epub 2019 Jun 9.

  PMID: 31116468 BACKGROUND

MeSH Terms

Interventions

Dietary Supplements; maltodextrin

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Replicate crossover trial design involving repeated administration of both supplementation and placebo conditions over 2 cycles involving 2 administrations of supplementation and 2 administrations of placebo in a randomized order (four periods in total). Additional information and details are available in Senn (2016). References Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016;35(7):966-977.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 21, 2025
• Primary Completion: October 26, 2025
• Study Completion: November 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)