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

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840098
• Other study ID #: 1-10-72-63-13
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: November 4, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• male gender

• 20<BMI<30

• Age > 20 years old

• Written consent before starting the study

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting
• Metabolism
• Nutrition Support

Intervention

Dietary Supplement:
• low leucine content drink

• high leucine content drink

• low leucine + HMB drink

• Control/carbohydrate

Behavioral:
• 36 hour fasting

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein metabolism after 36 hours fasting receiving different nutritional supplements.	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.	3 control period followed by 4 hours of nutritional drink intake	No