Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449287
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-31
Brief Title:
Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Strategies to Augment Ketosis Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAK
Brief Summary:
This project will be a three-group controlled 6-wk feeding study where all meals are prepared and provided to obese participants All participants will be fed a 25 energy-restricted diet Two diets will be very low in carbohydrate ie ketogenic diets designed to induce nutritional ketosis and fat loss Another diet will be low in fat and saturated fat but contain the same total calories Participants will be randomly assigned to a Ketone Supplement group who are provided an exogenous pre-formed source of beta-hydroxybutyrate BOHB or a Control group that only receives the standard ketogenic diet Randomization will be stratified based on insulin resistance sex and body composition to ensure balanced group assignment Because of timing of recruitment ie after most of the ketogenic groups have already completed the study the low-fat group will not be randomized Outcome measurements will be made at various intervals over the 6-wk intervention
Detailed Description:
This project will be a three-group controlled 6-wk feeding study where all meals are prepared and provided to obese participants All participants will be fed a 25 energy-restricted diet Two diets will be very low in carbohydrate ie ketogenic diets designed to induce nutritional ketosis and fat loss Another diet will be low in fat and saturated fat but contain the same total calories Participants will be randomly assigned to a Ketone Supplement group n12 who are provided an exogenous pre-formed source of beta-hydroxybutyrate BOHB or a Control group n12 that only receives the standard ketogenic diet Randomization will be stratified based on insulin resistance sex and body composition to ensure balanced group assignment Because of timing of recruitment ie after most of the ketogenic groups have already completed the study the low-fat group will not be randomized Outcome measurements will be made at various intervals over the 6-wk intervention Key outcome variables will include 1 Markers of KetosisKeto-Adaptation a Daily measures of BOHB capillary blood b Fasting serum BOHB and total ketones venous blood c Diurnal capillary blood ketones and urinary loss of BOHB and total ketones 2 Energy Balance and Body Composition a Body mass scale b Whole body and regional composition DXA c Nitrogen balance daily nitrogen intake - 24-hr urinary nitrogen loss d Resting energy expenditure and substrate oxidation indirect calorimetry e Adiposity myocardialepicardial fat liver fat visceral fat skeletal muscle fat by MRI f Microbiome stool collection to observe microbiota and the response to diet alteration 3 Cognitive and Behavioral a Computer-based cognitive function ANAM b Behavioral responses surveys 4 Cardio-Metabolic Risk a Metabolic panel b Circulating lipid panel total cholesterol LDL-C HDL-C TG c Glucose insulin HOMA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None