Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Control/carbohydrate

+ 36 hour fasting

+ low leucine content drink

Dietary SupplementBehavioral
Who is being recruted

Behavior

+ Feeding Behavior

+ Fasting

Over 20 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01840098
Principal SponsorUniversity of Aarhus
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorFeeding BehaviorFasting

Criteria

4 inclusion criteria required to participate
20 < BMI < 30
Age > 20 years old
Written consent before starting the study
male gender
8 exclusion criteria prevent from participating
Allergy for soya products ore egg
Diabetes
Dysregulated hypertension
Epilepsy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Isocaloric carbohydrate drink

Group II

Active Comparator
A soy protein drink

Group III

Active Comparator
A whey protein drink

Group IV

Active Comparator
Soy protein drink added HMB

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital

Aarhus C, DenmarkOpen Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital in Google Maps
CompletedOne Study Center