Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting

Not Applicable

Completed

• Conditions: Metabolism; Fasting; Nutrition Support
• Interventions: Dietary Supplement: Control/carbohydrate; Dietary Supplement: low leucine content drink; Dietary Supplement: high leucine content drink; Dietary Supplement: low leucine + HMB drink; Behavioral: 36 hour fasting

• Registration Number: NCT01840098
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to investigate metabolic effects of 3 different nutritional compounds.

Fasting (36 hours) creates a catabolic state that is comparable with the catabolic state seen in acute illness.

This study is a randomized, placebo cross-over study investigating 8 healthy men on 4 separated days (at least 3 weeks between trials).

* High leucine content drink

* Low leucine content drink

* Low leucine content drink + HMB

* Carbohydrate (isocaloric)

The investigators hypothesize that these nutritional supplements may counteract catabolic processes in different ways and degrees.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2014-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• male gender
• 20<BMI<30
• Age > 20 years old
• Written consent before starting the study

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Exclusion Criteria

• Allergy for soya products ore egg
• Diabetes
• Epilepsy
• Infection
• Immune defects
• Heart disease
• Dysregulated hypertension
• Participating in other trials using radioactive tracers or x-rays the last year.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control	36 hour fasting	Isocaloric carbohydrate drink
control	Control/carbohydrate	Isocaloric carbohydrate drink
low leucine content drink	low leucine content drink	A soy protein drink
high content of leucine drink	36 hour fasting	A whey protein drink
low leucine content drink	36 hour fasting	A soy protein drink
high content of leucine drink	high leucine content drink	A whey protein drink
low leucine content + HMB drink	36 hour fasting	Soy protein drink added HMB
low leucine content + HMB drink	low leucine + HMB drink	Soy protein drink added HMB

Primary Outcome Measures

Name	Time	Method
Protein metabolism after 36 hours fasting receiving different nutritional supplements.	3 control period followed by 4 hours of nutritional drink intake	Protein metabolism is measured with amino acid tracer techniques comparing marked amino acids from blood samples. Muscle and fat biopsies are obtained for signaling analysis. Indirect calorimetry measurements are used to compare metabolism in the control period and during the intervention.

Trial Locations

Locations (1)

Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital; 🇩🇰 Aarhus C, Denmark