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Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers (CASINO)

Primary Purpose

Ketones, Metabolism

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGLT2 inhibitor + low-carb diet
placebo + low-carb diet
Sponsored by
AdventHealth Translational Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketones, Metabolism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: M/F Age 18-60 years Weight stable (+/- 3 kg over past 6 months) Body mass index (BMI): 21-35 kg/m2 Otherwise healthy, as determined by medical history and laboratory tests Understands the procedures and agrees to participate by giving written informed consent Willing and able to comply with scheduled visits, laboratory tests, and other study procedures Exclusion criteria: Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to: History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator) Diagnosis of type 1 or type 2 diabetes mellitus, or prior diabetic ketoacidosis Blood pressure > 140/90 mm Hg Bleeding and clotting disorders Acute or chronic infection (such as TB, HIV or Hepatitis) Renal insufficiency (eGFR<60), nephritis, or chronic kidney disease Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic) Liver disease (liver function tests > 2 x normal; including NASH/NAFLD) Gastrointestinal disorders (including inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis) Past or present history of eating disorder (including binge eating) Past or present history of psychiatric disease, including major depressive illness or bipolar disorder, as well as claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry Unwilling or unable to eat the foods provided in the study diet A positive urine drug test for illicit drugs. Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years) Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection Regular smoking or regular nicotine use of any kind including chewing tobacco, snuff and vaping Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days. History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) Excluded medications include, but are not limited to: Any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) Anti-diabetic agents Recent change to medication and/or dosing in the past 3 months Blood thinner prescription medication Chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (a single aspirin daily if prescribed for cardioprotection will be allowed as will occasional use of aspirin and other non-steroidal drugs, provided that they are used for < 3 consecutive days and not during the period of metabolic testing)

Sites / Locations

  • AdventHealth Translational Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

SGLT2i + low-carb diet, then cross-over to counter condition

placebo + low-carb diet, then cross-over to counter condition

Outcomes

Primary Outcome Measures

Fasting plasma ketones
The primary objective of this study is to test the hypothesis that a low-carbohydrate diet combined with SGLT2i is sufficient to induce moderate ketosis (e.g. fasting ketones) in healthy volunteers.

Secondary Outcome Measures

24h AUC plasma ketones
The secondary objective of this study is to determine changes in 24h area-under-the curve (AUC) in plasma ketones.

Full Information

First Posted
December 15, 2022
Last Updated
April 26, 2023
Sponsor
AdventHealth Translational Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05662865
Brief Title
Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers
Acronym
CASINO
Official Title
Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers (CASINO)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Reviewing protocol to make amendments. Will resume study screening following this.
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth Translational Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to help us better understand how plasma ketones respond to a low-carb diet when combined with an SGLT2 inhibitor.
Detailed Description
Previous studies have shown that low-carb diets or SGLT2 inhibitors can increase plasma ketones in humans. This proof-of-concept study will test the idea that a combination of both can safely increase plasma ketones in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketones, Metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Proof-of-concept, single-group, randomized cross-over study design
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
SGLT2i + low-carb diet, then cross-over to counter condition
Arm Title
Group B
Arm Type
Other
Arm Description
placebo + low-carb diet, then cross-over to counter condition
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitor + low-carb diet
Intervention Description
15mg of ertugliflozin + low-carb diet (15%)
Intervention Type
Other
Intervention Name(s)
placebo + low-carb diet
Intervention Description
placebo + low-carb diet (15%)
Primary Outcome Measure Information:
Title
Fasting plasma ketones
Description
The primary objective of this study is to test the hypothesis that a low-carbohydrate diet combined with SGLT2i is sufficient to induce moderate ketosis (e.g. fasting ketones) in healthy volunteers.
Time Frame
22 days
Secondary Outcome Measure Information:
Title
24h AUC plasma ketones
Description
The secondary objective of this study is to determine changes in 24h area-under-the curve (AUC) in plasma ketones.
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: M/F Age 18-60 years Weight stable (+/- 3 kg over past 6 months) Body mass index (BMI): 21-35 kg/m2 Otherwise healthy, as determined by medical history and laboratory tests Understands the procedures and agrees to participate by giving written informed consent Willing and able to comply with scheduled visits, laboratory tests, and other study procedures Exclusion criteria: Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to: History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator) Diagnosis of type 1 or type 2 diabetes mellitus, or prior diabetic ketoacidosis Blood pressure > 140/90 mm Hg Bleeding and clotting disorders Acute or chronic infection (such as TB, HIV or Hepatitis) Renal insufficiency (eGFR<60), nephritis, or chronic kidney disease Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic) Liver disease (liver function tests > 2 x normal; including NASH/NAFLD) Gastrointestinal disorders (including inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis) Past or present history of eating disorder (including binge eating) Past or present history of psychiatric disease, including major depressive illness or bipolar disorder, as well as claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry Unwilling or unable to eat the foods provided in the study diet A positive urine drug test for illicit drugs. Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years) Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection Regular smoking or regular nicotine use of any kind including chewing tobacco, snuff and vaping Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days. History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) Excluded medications include, but are not limited to: Any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) Anti-diabetic agents Recent change to medication and/or dosing in the past 3 months Blood thinner prescription medication Chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (a single aspirin daily if prescribed for cardioprotection will be allowed as will occasional use of aspirin and other non-steroidal drugs, provided that they are used for < 3 consecutive days and not during the period of metabolic testing)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Erickson, PhD
Organizational Affiliation
AdventHealth Translational Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth Translational Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.adventhealthresearchinstitute.com/research/translational-research
Description
AdventHealth Translational Research Institute, Orlando, FL

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Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers

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