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NCT05551455
Endocrinological and Physiological Responses to Short-term Reduced Carbohydrate Availability in Males
NA trial testing Nutritional/dietary intake manipulation ('Normal') in Energy Supply; Deficiency in 8 participants. Completed in 9 December 2022.
9 December 2022
Quick facts
| Lead sponsor | Liverpool John Moores University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 8 |
| Start date | 4 May 2022 |
| Primary completion | 9 December 2022 |
| Estimated completion | 9 December 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Nutritional/dietary intake manipulation ('Normal')
- Nutritional/dietary intake manipulation ('Low')
Conditions studied
- Energy Supply; Deficiency — all drugs for Energy Supply; Deficiency →
- Carbohydrate Availability — all drugs for Carbohydrate Availability →
Sponsor
Liverpool John Moores University
Who can join
Adults 18 to 40, male only, with Energy Supply; Deficiency or Carbohydrate Availability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Using a randomised crossover design, nine weight-stable men, aged 18 - 40 years old, will be recruited via convenience sampling from the staff and student body of LJMU and local area. Participants will be asked to follow two 4-day (\~96 hours) periods of tightly controlled exercise energy expenditure (15 kcal/kg FFM/day \[cycling\]) and dietary intake (60 kcal/kg FFM/day) to compare a state of 'normal' energy availability (or energy balance; equivalent to 45 kcal/kg FFM/day) with concomitant 1: normal carbohydrate availability ('Normal'; \~60% of dietary intake from carbohydrate) and 2: low carbohydrate availability ('LCHF', \~1.5 g/kg carbohydrate per day, \~70 - 80% dietary intake from fat). This approximates the amount of carbohydrate consumed by an individual in a state of LEA through consuming 10 kcal/kg FFM/day with 50% of intake from carbohydrate, or \~1.5 g/kg/day of carbohydrate. In both experimental phases we will measure endocrine, metabolic and physiological parameters.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05551455
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Related trials
Other recruiting trials for Energy Supply; Deficiency
Currently open trials in the same condition.
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- NCT06394401 — Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit · NA · recruiting
Other Liverpool John Moores University trials
Trials by the same sponsor.
- NCT07454317 — Biofeedback Intervention for Paroxysmal Atrial Fibrillation · NA · not yet recruiting
- NCT07469852 — Effects of Caffeine Ingestion on Morning Cognitive and 4-km Time Trial Performance in Males · Phase 1, PHASE2 · active not recruiting
- NCT07366931 — The Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes · Phase 1, PHASE2 · not yet recruiting
- NCT07466732 — Effects of Caffeine Ingestion on Morning Cognitive and Muscle Repeated Sprint Performance in Males · EARLY_PHASE1 · enrolling by invitation
- NCT07341243 — Exercising in Hot Conditions: How Does it Effect Blood Glucose in People With T1D · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05551455 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Liverpool John Moores University
- Last refreshed: 17 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05551455.
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