Understanding the Paradoxical Rise in Blood Glucose in the Context of a Low-carbohydrate Diet

NCT07713316 | Completed

• 1 other identifier: IRB2021-015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project was to elucidate the phenomenon of elevated blood glucose in the context of dietary carbohydrate restriction. Accordingly, we sought to quantify glucagon, and related hormones, between individuals that are adhering to a low-carbohydrate diet that manifests with normal vs. elevated glucose. Moreover, we sought to test the dynamic effect of macronutrients on these same outcomes. Each participant completed 3 testing periods that included the consumption of a glucose drink, protein drink, or fat (olive oil) drink in a random order and separated by at least 2 days. Each drink was matched for volume and total calories and bloodwork was taken every 30 minutes to assess the outcomes of interest.

Conditions

Elevated Blood Glucose; Low-carbohydrate Diet

Keywords

ketogenic diet; blood glucose; metabolic health; glycemic control

Outcome Measures

Primary Outcomes (2)

• Interstitial glucose (continuous glucose monitoring)

  Interstitial subcutaneous glucose concentrations were measured using the Freestyle Libre 2 continuous glucose monitor (CGM) (Abbott Laboratories).

  2 hours after consuming the beverage

• Plasma Hormone Concentrations

  The Human Metabolic Hormone Magnetic Bead Panel multiplex kit (Sigma-Aldrich, Inc., St. Louis, MO; Catalog # HMHEMAG-34K) was utilized to quantify the plasma concentrations of 13 metabolic hormones including amylin, ghrelin, glucagon, gluca-gon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), inter-leukin 6 (IL-6), insulin, c-peptide, leptin, monocyte chemoattractant protein-1 (MCP-1), pancreatic polypeptide (PP), peptide YY (PYY), and tumor necrosis factor alpha (TNF-α). Venipuncture took place in the human performance laboratory by a trained phlebotomist using standard phlebotomy procedures.

  At baseline and then at 30, 60, 90, and 120 minutes after consuming the beverage

Secondary Outcomes (5)

• Blood Pressure

  Immediately before intervention

• Weight

  Before the start of the intervention (baseline visit).

• Height

  Before the start of the intervention (baseline visit).

• Body Composition Estimates

  Before the start of the intervention (baseline visit).

• Body Mass Index Computation

  Before the start of the intervention (baseline visit).

Other Outcomes (1)

• Heart Rate

  Prior to phlebotomy

Study Arms (3)

Carbohydrate Drink

EXPERIMENTAL

carbohydrate

Dietary Supplement: Carbohydrate Drink

Fat Drink

ACTIVE COMPARATOR

Fat

Dietary Supplement: Fat Drink

Protein Drink

ACTIVE COMPARATOR

Protein

Dietary Supplement: Protein Drink

Interventions

Carbohydrate Drink DIETARY_SUPPLEMENT

300 kcal of dextrose mixed in water.

Carbohydrate Drink

Protein Drink DIETARY_SUPPLEMENT

300 kcal of whey protein in water.

Protein Drink

Fat Drink DIETARY_SUPPLEMENT

300 kcal of olive oil mixed in water.

Fat Drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weight stable (± 3% body weight) for the past 3 months
• adhering to a low-carbohydrate (50g carbohydrates or less per day) diet at least 2 weeks prior to and during the duration of the one-month study

You may not qualify if:

• unwilling to provide written consent
• diagnosed with chronic disease(s) including cardiac disease, cancer, or liver disease,
• pregnant or lactating,
• taking medications that alter metabolism,
• allergies to latex, cow's milk/milk products, olives, chlorhexidine, or dextrose,
• have had more than 5 x-rays in the past year.

Sponsors & Collaborators

• Brigham Young University: lead
• Levels Health Inc.: collaborator

Study Sites (1)

Brigham Young University

Provo, Utah, 84606, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benjamin Bikman, PhD

  Brigham Young University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 20, 2026
• Study Start: May 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 17, 2022
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available immediately. No end date.

Locations

US (1)