The mechanism whereby an exogenous ketone drink lowers blood glucose

Not Applicable

Completed

• Conditions: Glucose and ketone bodies metabolism; Not Applicable

• Registration Number: ISRCTN16169021
• Lead Sponsor: TdeltaS Ltd

Brief Summary

2021 Results article in https://doi.org/10.1002/edm2.300 (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-11
• Study Completion: 2018-07-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified