Ketone Supplementation, Glucose Control, and Cardiovascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2020-12-31

Brief Summary

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Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an elevated risk of type 2 diabetes.

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Detailed Description

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Conditions

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Hyperglycemia, Postprandial Overweight and Obesity Diabetes Mellitus Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental

* Participants will consume 20 g of an active oral exogenous ketone monoester supplement 15 minutes prior to each meal of the day for a 14-day period.
* Pre-intervention (baseline) and post-intervention measurements will be obtained before and immediately after the 14-day period.
* All meals will be provided throughout the supplementation period
* Participants will wear a continuous glucose monitor for 6 consecutive days during the supplementation period.

Group Type EXPERIMENTAL

Exogenous ketone monoester

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Placebo

Participants will consume a flavor matched placebo drink and undergo the same procedures described in the Experimental Arm

Group Type PLACEBO_COMPARATOR

Exogenous ketone monoester

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Interventions

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Exogenous ketone monoester

Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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HVMN ketone monoester supplement

Eligibility Criteria

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Inclusion Criteria

* Elevated waist circumference (\>102 cm for males, \>88 cm for females) and/or Obesity (BMI \> 30 kg/m2) and/or Diagnoses of prediabetes based on A1C (5.7-6.4%) and/or fasting plasma glucose (5.6-6.9 mmol/l) using ADA criteria

Exclusion Criteria

* Competitively trained endurance athlete
* Actively attempting to lose weight
* History of mental illness or existing neurological disease(s)
* Previous cardiovascular events (i.e., heart attack, stroke)
* Diagnoses of diabetes
* Hypoglycemia
* Irritable bowel syndrome or inflammatory bowel disease
* Taking medication that may interfere with insulin sensitivity
* Currently following a ketogenic diet or taking ketone supplements
* Unable to commit for 2 separate 14-day trials and unable to follow a controlled diet

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No