Consumption of a ketone ester Not Applicable
Conditions
Interventions
Consumption of a drink containing 25 mg of a ketone ester three times a day for 28 days. Participants will be asked to keep a dietary log, to take daily glucose and blood ketone pinprick measurements
Sponsors
TdeltaS Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 26/10/2018: This study is currently only recruiting people with type 2 diabetes. People with type 2 diabetes: 1. Type2 diabetes patients who don’t use or need insulin and who have had the same treatment for the last 6 months. Confirmation of eligibility from your GP will be requested. 2. Fluent in English 3. Males, or females using hormonal birth control if sexually active 4. Aged 18-70 Healthy volunteers (not currently open to recruitment): 1. Participants must be fluent in English, have no communication impairments and should be willing and able to give informed consent for participation in the trial 2. Aged 18 – 70 (inclusive) 3. With no known medical diagnosis 4. Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before the first trial dose and no individual doses in the final two weeks other than over the counter analgesics, vitamins and mineral supplements or, for females, oral contraceptives 5. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner mechanical or pharmacological contraception during the trial and for 3 months thereafter 6. In the Investigator’s opinion, is able and willing to comply with all trial requirements 7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial Previous participant inclusion criteria: 1. Participants must be fluent in English, have no communication impairments and should be willing and able to give informed consent for participation in the trial 2. Aged 18 – 70 (inclusive) 3. With no known medical diagnosis 4. Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before the first trial dose and no individual doses in the final two weeks other than over the counter analgesics, vitamins and mineral supplements or, for females, oral contraceptives 5. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner mechanical or pharmacological contraception during the trial and for 3 months thereafter 6. In the Investigator’s opinion, is able and willing to comply with all trial requirements 7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
Exclusion criteria
Exclusion criteria: 1. Female participant who is pregnant, lactating or planning pregnancy during the trial 2. Significant renal or hepatic impairment 3. Scheduled elective procedures requiring general anaesthesia during the trial 4. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5. Participants who have participated in another research trial involving an investigational product in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and weekly after the start of the intervention until the end of participation: 1. Tolerability, measured with the reported frequency and severity of adverse effects using open questions: "Have you experienced any unpleasant symptoms in the last week?","How frequently?" and all symptoms graded as "mild", "moderate" or "severe" 2. Safety, assessed with blood samples, particularly levels of beta-hydroxybutyrate and pH | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and weekly after the start of the intervention until the end of participation: 1. Weight and body composition measured with electric bioimpedance 2. Insulin sensitivity assessed with the HOMA-IR score | — |
Countries
England, United Kingdom
Contacts
Public ContactLuis Adrian Soto Mota
Outcome results
None listed