Nutritional ketosis (achieved through consumption of a ketone ester drink) Nutritional, Metabolic, Endocrine Nutritional ketosis (achieved through consumption of a ketone ester drink)
Conditions
Interventions
This study has 4 conditions. Participants are randomly assigned to arms A (nutritional ketosis) and B (control). Randomisation is achieved by using a true random number generator. Given the demanding
Sponsors
TdeltaS Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent; 2. Males, or females taking the combined oral contraceptive pill 3. Aged 18-45 years Arms A-C: 1. Participating in regular cardiovascular exercise Arm D; 1. Meeting 'inactive' or 'minimally active' criteria as defined by the International Physical Activity Questionnaire (IPAQ)
Exclusion criteria
Exclusion criteria: 1. Inability to perform the required bicycle ergometer exercise 2. Any history or indication at screening of cardiovascular disease 3. Any history or indication at screening of metabolic disease 4. Impaired glucose tolerance or diabetes as defined by an oral glucose tolerance test 5. Pregnancy or current breastfeeding 6. Any other cause which, in the opinion of the investigator, may affect the volunteer's ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in basal and exercise substrate metabolism: 1. Respiratory gases, assessed by indirect calorimetry at the baseline and post-intervention exercise tests 2. Blood metabolites, assessed using bench-top assays at the baseline and post-intervention exercise and glucose tests 3. Abundance of pre- and post-exercise metabolites in skeletal muscle samples, assessed using metabolomics at the baseline and post-intervention exercise tests 4. Intramuscular triglyceride and glycogen content of skeletal muscle and adipose tissue samples, assessed using histological analysis at the baseline and post-intervention exercise tests 5. Enzymes involved in the metabolism of fats, carbohydrates, proteins and ketone bodies, assessed at the baseline and post-intervention tests using the following methods: 5.1. Western blot 5.2. Proteomics 5.3. Q-PCR 6. 13C glucose oxidation, assessed using mass spectrometry at the baseline and post-intervention glucose tolerance tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in exercise performance and training state: 1. Exercise performance, assessed at each exercise session (8 sessions) by the time to exhaustion and training impule (training volume x intensity) 2. Mood, assessed using the following questionnaires on 7 study days (VO2max test, baseline test, dietary habituation day 2, exercise intervention days 2, 4 and 6, and post-intervention): 2.1. Daily analysis of life demands for athletes (DALDA) 2.2. Profile of mood state (POMS) | — |
Countries
United Kingdom
Outcome results
None listed