Skip to main content
OpenTrials
Completed

NCT Number: NCT06449287

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ketogenic Diet Acid-Base Imbalance Acidosis Body Weight Body Weight Changes Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

The diet intervention will start after all baseline testing is complete

Blood Draw

Biological

Blood samples will be collected biweekly.

Ketone/Glucose Monitoring

Biological

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

Body Composition

Other

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

Urine Analysis

Biological

24 hour urine collection will be done biweekly.

Neuropsychological Measures - ANAM

Behavioral

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.

Primary outcomes

  1. Daily Ketone/Glucose Monitoring

    Time frame: 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.

  2. Cholesterol (mg/dl)

    Time frame: up to six weeks

    Fasting venous blood will be collected biweekly to measure cholesterol.

  3. Insulin (mIU/L)

    Time frame: up to six weeks

    Fasting venous blood will be collected biweekly.

  4. Glucose (mg/dL)

    Time frame: up to six weeks

    Fasting venous blood will be collected biweekly.

  5. Lean Mass (kg)

    Time frame: up to six weeks

    DEXA Scanning will be biweekly to assess lean mass

  6. Fat Mass (kg)

    Time frame: up to six weeks

    DEXA Scanning will be biweekly to assess fat mass

Secondary outcomes

  1. Neuropsychological Outcome 1 - Reaction time (Throughput)

    Time frame: 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.

  2. Neuropsychological Outcome 1 - Visual Short Term Memory (Throughput)

    Time frame: 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.

  3. Neuropsychological Outcome 1 - Spatial Processing (Throughput)

    Time frame: 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.

  4. Urine Chemistries

    Time frame: up to 6 weeks

    24 hour urine will be collected biweekly and analyzed for urine chemistries

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: STAK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.