Ketosis Clinical Trial
— KETOOfficial title:
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
Verified date | May 2024 |
Source | Gødstrup Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).
Status | Completed |
Enrollment | 16 |
Est. completion date | April 11, 2024 |
Est. primary completion date | April 11, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - BMI < 30 kg/m2 - Safe contraception if women in childbearing age - Normal biochemical screening Exclusion Criteria: - Pregnancy or breast feeding - Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease - Daily use of prescription drugs (expect for contraceptives) - Alcohol or drug abuse - Periodic fasting - Routinely intake of ketogenic diet |
Country | Name | City | State |
---|---|---|---|
Denmark | The University Clinic of Nephrology and Hypertension | Herning | Jutland |
Lead Sponsor | Collaborator |
---|---|
Gødstrup Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GFR | Change in GFR measured by Tc99m-DTPA clearance | Measured after each treatment period (day 6 and approximately day 26) | |
Primary | Renal Blood Flow (RBF) | Change in RBF determined by water based PET/CT scans | Subjects are scanned after each treatment period (day 6 and approximately day 26) | |
Secondary | 24-hour blood pressure | Change in systolic 24-hour blood pressure | Measured after each treatment period (day 6 and approximately day 26) | |
Secondary | Vasoactive hormones | Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin | Measured after each treatment period (day 6 and approximately day 26) | |
Secondary | Beta-hydroxybutyrate | Change ind p-beta-hydroxybutyrate | Measured after each treatment period (day 6 and approximately day 26) | |
Secondary | Renal tubular transport proteins | Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC) | Measured after each treatment period (day 6 and approximately day 26) |
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