Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840098
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Nikolaj Fibiger Rittig, 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.


Condition or disease Intervention/treatment Phase
Fasting Metabolism Nutrition Support Dietary Supplement: low leucine content drink Dietary Supplement: high leucine content drink Dietary Supplement: low leucine + HMB drink Dietary Supplement: Control/carbohydrate Behavioral: 36 hour fasting Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine

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
Dietary Supplement: low leucine content drink
Behavioral: 36 hour fasting
Active Comparator: high content of leucine drink
A whey protein drink
Dietary Supplement: high leucine content drink
Behavioral: 36 hour fasting
Active Comparator: low leucine content + HMB drink
Soy protein drink added HMB
Dietary Supplement: low leucine + HMB drink
Behavioral: 36 hour fasting



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840098


Locations
Layout table for location information
Denmark
Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nikolaj Fibiger Rittig, MD (medical graduate) and Ph.d.-student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01840098     History of Changes
Other Study ID Numbers: 1-10-72-63-13
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrients
Growth Substances
Physiological Effects of Drugs