Echocardiographic Changes After 3-hydroxy Butyrate+Whey Intake

NCT04037722 | Completed

• 1 other identifier: Ketone Heart Study
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions. Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).

Conditions

Cardiac Output; Endotoxemia; Catabolic State; Echocardiography

Keywords

Cardiac Output; Endotoxemia; Ketone bodies; 3-hydroxy butyrate; Whey protein; Catabolic State

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular outflow tract velocity time integral

  Echocardiographic changes in left ventricular outflow tract velocity time integral from the basal period and after 1.5 hours of intervention

  Measured during the basal period and after 1.5 hours of intervention

Secondary Outcomes (12)

• Changes in Left Ventricular Ejection Fraction (LVEF)

  Measured during the basal period and after 1.5 hours of intervention

• Changes in Global Longitudinal Strain (GLS)

  Measured during the basal period and after 1.5 hours of intervention

• Changes in S´ Max

  Measured during the basal period and after 1.5 hours of intervention

• Changes in blood pressure

  Measured during the basal period and after 1.5 hours of intervention

• Changes in heart rate

  Measured during the basal period and after 1.5 hours of intervention

Study Arms (3)

Healthy + Whey

EXPERIMENTAL

Healthy conditions (overnight fast)

Dietary Supplement: Whey

Catabolic + Whey

EXPERIMENTAL

Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))

Dietary Supplement: Whey

Catabolic + 3-OHB / Whey

EXPERIMENTAL

Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))

Dietary Supplement: 3-OHB + Whey

Interventions

Whey DIETARY_SUPPLEMENT

45 g whey + 20 g maltodextrin

Catabolic + Whey; Healthy + Whey

3-OHB + Whey DIETARY_SUPPLEMENT

50 g ketone + 45 g whey + 20 g maltodextrin

Catabolic + 3-OHB / Whey

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20-40 years of age
• Body mass index between 20-30 kg/m\^2
• Healthy
• Oral and written consent forms obtained prior to study day

You may not qualify if:

• Recent immobilization of an extremity that is not fully rehabilitated
• Lactose, lidocain or rubber allergies
• Current disease
• Use of anabolic steroids
• Smoking
• Former major abdominal surgery (Or current problems with the GI tract)
• \>10 hours of exercise/weak
• Present ketogenic diets or high-protein diets
• Blood doner that does not want to discontinue blood donations until study completion
• Pending MR scan

Sponsors & Collaborators

• University of Aarhus: lead
• Arla Food Ingredients, Arla Viby.: collaborator
• Aarhus University Hospital Skejby: collaborator

Study Sites (1)

Medical Research Labarotory, DoH, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Endotoxemia

Interventions

Whey

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Niels Moeller, Professor

  Aarhus University Hospital and Institute of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Interventions (saline/LPS) or whey/3-OHB+whey will be given by the investigator, and the echocardiography will be performed by another blinded investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a randomized crossover design, eight healthy lean young men will undergo either: i) Healthy conditions (overnight fast) + whey protein ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + whey protein iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + 3-OHB/whey protein

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 30, 2019
• Study Start: June 17, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: June 11, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)