Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.

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.

Conditions

• Ketogenic Diet
• Weight Loss

Interventions

OTHER

Diet

The diet intervention will start after all baseline testing is complete

BIOLOGICAL

Blood Draw

Blood samples will be collected biweekly.

BIOLOGICAL

Ketone/Glucose Monitoring

Hand-held glucometer will be used daily to monitor dietary intervention adherence.

OTHER

Body Composition

DEXA Scanning will be done pre-, mid-, and post- intervention.

BIOLOGICAL

Urine Analysis

24 hour urine collection will be done biweekly.

BEHAVIORAL

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.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Jeff Volek, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-05

Primary Completion

2019-03-01

Completion

2019-08-21

Countries

• United States

Study Locations