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

NCT05662865 | Active Not Recruiting Phase 1

• 1 other identifier: 1921572
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketones, Metabolism

Outcome Measures

Primary Outcomes (1)

• Fasting ketones

  To determine if the primary study objective was achieved (e.g. SGLT2i combined with dietary carbohydrate restriction achieves moderate ketosis, safely and tolerably, in healthy, non-diabetic adults), we will use a binary decision (yes/no) for each participant, based on fasting capillary ketones.

  28 days

Secondary Outcomes (1)

• 24h AUC plasma ketones

  28 days

Study Arms (1)

Single, Experimental Group

EXPERIMENTAL

SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction

Drug: SGLT2 inhibitor; Other: Controlled, Adaptive Study Diet

Interventions

SGLT2 inhibitor DRUG

SGTL2i (15 mg) once daily

Also known as: ertugliflozin

Single, Experimental Group

Controlled, Adaptive Study Diet OTHER

An adaptive study diet combined with SGLT2i, which consists of four sequential, 7-day long phases in which dietary carbohydrates are gradually reduced (50% carbs, 30% carbs, 20% carbs, and 10% carbs) based on safety and tolerability to achieve moderate ketosis. All diet phases are isocaloric. All meals are provided on an inpatient unit.

Single, Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Related Links

• AdventHealth Translational Research Institute, Orlando, FL

MeSH Terms

Conditions

Ketosis

Interventions

Sodium-Glucose Transporter 2 Inhibitors; ertugliflozin; Control Groups

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Melissa Erickson, PhD

  AdventHealth Translational Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof-of-concept, single-group, study design

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: March 16, 2023
• Primary Completion: July 23, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)