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

November 4, 2014 updated by: Nikolaj Fibiger Rittig, University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Isocaloric carbohydrate drink
Dietary supplement: Control/carbohydrate
Behavioral: 36 hour fasting
Active Comparator: low leucine content drink
A soy protein drink
Behavioral: 36 hour fasting
Dietary supplement: low leucine content drink
Active Comparator: high content of leucine drink
A whey protein drink
Behavioral: 36 hour fasting
Dietary supplement: high leucine content drink
Active Comparator: low leucine content + HMB drink
Soy protein drink added HMB
Behavioral: 36 hour fasting
Dietary supplement: low leucine + HMB drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein metabolism after 36 hours fasting receiving different nutritional supplements.
Time Frame: 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.
3 control period followed by 4 hours of nutritional drink intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1-10-72-63-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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