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

NCT ID: NCT01840098

Last Updated: 2014-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fasting Metabolism Nutrition Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

Isocaloric carbohydrate drink

Group Type ACTIVE_COMPARATOR

Control/carbohydrate

Intervention Type DIETARY_SUPPLEMENT

36 hour fasting

Intervention Type BEHAVIORAL

low leucine content drink

A soy protein drink

Group Type ACTIVE_COMPARATOR

low leucine content drink

Intervention Type DIETARY_SUPPLEMENT

36 hour fasting

Intervention Type BEHAVIORAL

high content of leucine drink

A whey protein drink

Group Type ACTIVE_COMPARATOR

high leucine content drink

Intervention Type DIETARY_SUPPLEMENT

36 hour fasting

Intervention Type BEHAVIORAL

low leucine content + HMB drink

Soy protein drink added HMB

Group Type ACTIVE_COMPARATOR

low leucine + HMB drink

Intervention Type DIETARY_SUPPLEMENT

36 hour fasting

Intervention Type BEHAVIORAL

Interventions

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low leucine content drink

Intervention Type DIETARY_SUPPLEMENT

high leucine content drink

Intervention Type DIETARY_SUPPLEMENT

low leucine + HMB drink

Intervention Type DIETARY_SUPPLEMENT

Control/carbohydrate

Intervention Type DIETARY_SUPPLEMENT

36 hour fasting

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Nikolaj Fibiger Rittig

MD (medical graduate) and Ph.d.-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14.

Reference Type DERIVED
PMID: 37844838 (View on PubMed)

Rittig N, Bach E, Thomsen HH, Moller AB, Hansen J, Johannsen M, Jensen E, Serena A, Jorgensen JO, Richelsen B, Jessen N, Moller N. Anabolic effects of leucine-rich whey protein, carbohydrate, and soy protein with and without beta-hydroxy-beta-methylbutyrate (HMB) during fasting-induced catabolism: A human randomized crossover trial. Clin Nutr. 2017 Jun;36(3):697-705. doi: 10.1016/j.clnu.2016.05.004. Epub 2016 May 25.

Reference Type DERIVED
PMID: 27265181 (View on PubMed)

Other Identifiers

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1-10-72-63-13

Identifier Type: -

Identifier Source: org_study_id

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