Ketogenic Diet, Weight Loss
Conditions
Keywords
ketones, metabolism, weight loss
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 (i.e., 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 (i.e., 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 (i.e., 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 (n=12) who are provided an exogenous pre-formed source of beta-hydroxybutyrate (BOHB) or a Control group (n=12) 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 (i.e., 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 Ketosis/Keto-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 (myocardial/epicardial 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
Interventions
OTHERDiet
The diet intervention will start after all baseline testing is complete
BIOLOGICALBlood Draw
Blood samples will be collected biweekly.
BIOLOGICALKetone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
OTHERBody Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
BIOLOGICALUrine Analysis
24 hour urine collection will be done biweekly.
BEHAVIORALNeuropsychological Measures - ANAM
The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). This cognitive battery is a library of computer-based tests of domains including attention, concentration, reaction time, memory, processing speed, decision-making, and executive function.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI \>27 and =35 kg/m2
Exclusion criteria
* have diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or using diabetic medications. * Currently consuming a low-carbohydrate diet * Weight loss of \>10% in past 6 months -Currently pregnant or nursing, or planning to become pregnant during the study * Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) * Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat Mass (kg) | up to six weeks | DEXA Scanning will be biweekly to assess fat mass |
| Cholesterol (mg/dl) | up to six weeks | Fasting venous blood will be collected biweekly to measure cholesterol. |
| Insulin (mIU/L) | up to six weeks | Fasting venous blood will be collected biweekly. |
| Glucose (mg/dL) | up to six weeks | Fasting venous blood will be collected biweekly. |
| Lean Mass (kg) | up to six weeks | DEXA Scanning will be biweekly to assess lean mass |
| Daily Ketone/Glucose Monitoring | Up to 6 weeks | Daily fasting glucose/ketones will be assessed using capillary finger stick lancing. A small drop of blood will be obtained once daily, while fasting, using enzymatic strips fitted for a handheld analyzer (KetoMojo). All the data will be stored in the device's internal memory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological Outcome 1 - Visual Short Term Memory (Throughput) | up to six weeks | The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures verbal short-term memory by having the users memorize a set of characters and then indicate as single characters are presented on the screen whether the character was part of the memory set. Results are measured by throughput. |
| Neuropsychological Outcome 1 - Spatial Processing (Throughput) | up to six weeks | The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures visual spatial skills and mental rotation by having the users compare the equivalence of two 4-bar histograms, the first of which is displayed upright and the second of which is displayed after a 90° rotation either clockwise or counterclockwise. Results are measured by Throughput. |
| Urine Chemistries | up to 6 weeks | 24 hour urine will be collected biweekly and analyzed for urine chemistries |
| Neuropsychological Outcome 1 - Reaction time (Throughput) | up to six weeks | The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures SRT by presenting the user with a series of \* symbols to which they must respond as quickly as possible each time the symbol appears. Results are measured by throughput. |
Countries
United States
Outcome results
None listed