NCT01840098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

April 17, 2013

Last Update Submit

November 4, 2014

Conditions

FastingMetabolismNutrition Support

Outcome Measures

Primary Outcomes (1)

  • Protein metabolism after 36 hours fasting receiving different nutritional supplements.

    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

Study Arms (4)

control

ACTIVE COMPARATOR

Isocaloric carbohydrate drink

Dietary Supplement: Control/carbohydrateBehavioral: 36 hour fasting

low leucine content drink

ACTIVE COMPARATOR

A soy protein drink

Dietary Supplement: low leucine content drinkBehavioral: 36 hour fasting

high content of leucine drink

ACTIVE COMPARATOR

A whey protein drink

Dietary Supplement: high leucine content drinkBehavioral: 36 hour fasting

low leucine content + HMB drink

ACTIVE COMPARATOR

Soy protein drink added HMB

Dietary Supplement: low leucine + HMB drinkBehavioral: 36 hour fasting

Interventions

low leucine content drinkDIETARY_SUPPLEMENT
low leucine content drink
high leucine content drinkDIETARY_SUPPLEMENT
high content of leucine drink
low leucine + HMB drinkDIETARY_SUPPLEMENT
low leucine content + HMB drink
Control/carbohydrateDIETARY_SUPPLEMENT
control
36 hour fastingBEHAVIORAL
controlhigh content of leucine drinklow leucine content + HMB drinklow leucine content drink

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male gender
  • \<BMI\<30
  • Age \> 20 years old
  • Written consent before starting the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital

Aarhus C, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 37844838DERIVED

  • 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.

    PMID: 27265181DERIVED

MeSH Terms

Conditions

Fasting

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD (medical graduate) and Ph.d.-student

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 25, 2013

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

DK(1)