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Completed

NCT Number: NCT01840098

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

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.

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Key information

Conditions

Fasting Behavior Feeding Behavior Metabolism Nutrition Support

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low leucine content drink

Dietary Supplement

high leucine content drink

Dietary Supplement

low leucine + HMB drink

Dietary Supplement

Control/carbohydrate

Dietary Supplement

36 hour fasting

Behavioral

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2013
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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