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Clinical trial

Strategies to Augment Ketosis: Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.

ID
Name
2017H0395
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 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.
Trial arms
Trial start
2018-07-05
Estimated PCD
2019-03-01
Trial end
2019-08-21
Status
Completed
Treatment
Diet
The diet intervention will start after all baseline testing is complete
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Blood Draw
Blood samples will be collected biweekly.
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Ketone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Urine Analysis
24 hour urine collection will be done biweekly.
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Neuropsychological 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.
Arms:
Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo
Size
37
Primary endpoint
Daily Ketone/Glucose Monitoring
Up to 6 weeks
Cholesterol (mg/dl)
up to six weeks
Insulin (mIU/L)
up to six weeks
Glucose (mg/dL)
up to six weeks
Lean Mass (kg)
up to six weeks
Fat Mass (kg)
up to six weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2024-06-10

1 organization

3 products

2 indications

Organization
Ohio State University
Product
Blood Draw
Indication
Ketogenic diet
Indication
Unintentional Weight Loss
Product
Ketone/Glucose Monitoring
Product
Urine Analysis