FastingNCT01840098
Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting
A study testing low leucine content drink, high leucine content drink and low leucine + HMB drink in people with Fasting and Metabolism, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting, Metabolism, Nutrition Support
- What is being tested?
- low leucine content drink, high leucine content drink and low leucine + HMB drink
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender
- 20<BMI<30
- Age > 20 years old
- Written consent before starting the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital
Aarhus C, 8000
About this study
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.
- Conditions
- Fasting, Metabolism, Nutrition Support
- Being tested
- low leucine content drink, high leucine content drink, low leucine + HMB drink, Control/carbohydrate, 36 hour fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low leucine content drinkDietary supplement
high leucine content drinkDietary supplement
low leucine + HMB drinkDietary supplement
Control/carbohydrateDietary supplement
36 hour fastingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Isocaloric carbohydrate drink Receives: Dietary Supplement: Control/carbohydrate; Behavioral: 36 hour fasting |
| low leucine content drink | Active comparator | A soy protein drink Receives: Dietary Supplement: low leucine content drink; Behavioral: 36 hour fasting |
| high content of leucine drink | Active comparator | A whey protein drink Receives: Dietary Supplement: high leucine content drink; Behavioral: 36 hour fasting |
| low leucine content + HMB drink | Active comparator | Soy protein drink added HMB Receives: Dietary Supplement: low leucine + HMB drink; Behavioral: 36 hour fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 control period followed by 4 hours of nutritional drink intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Fibiger Rittig, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840098
- Sponsor's protocol ID
- 1-10-72-63-13
- Status last verified
- Nov 2014
- First submitted
- 17 Apr 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37844838Rittig 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.
PubMed 27265181
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting
- ClinicalTrials.gov ID
- NCT01840098
- Acronym / sponsor ID
- 1-10-72-63-13
- Conditions
- Fasting, Metabolism, Nutrition Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Dietary Supplement: Control/carbohydrate, Behavioral: 36 hour fastingIsocaloric carbohydrate drink |
| low leucine content drink | Active comparator | Dietary Supplement: low leucine content drink, Behavioral: 36 hour fastingA soy protein drink |
| high content of leucine drink | Active comparator | Dietary Supplement: high leucine content drink, Behavioral: 36 hour fastingA whey protein drink |
| low leucine content + HMB drink | Active comparator | Dietary Supplement: low leucine + HMB drink, Behavioral: 36 hour fastingSoy protein drink added HMB |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male gender
- 20<BMI<30
- Age > 20 years old
- Written consent before starting the study
Key exclusion criteria (8 listed)
- Allergy for soya products ore egg
- Diabetes
- Epilepsy
- Infection
- Immune defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low leucine content drink | Dietary supplement | low leucine content drink |
| high leucine content drink | Dietary supplement | high content of leucine drink |
| low leucine + HMB drink | Dietary supplement | low leucine content + HMB drink |
| Control/carbohydrate | Dietary supplement | control |
| 36 hour fasting | Behavioural | control, high content of leucine drink, low leucine content + HMB drink, low leucine content drink |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Derived from this study: PubMed 37844838Pedersen 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.
- Derived from this study: PubMed 27265181Rittig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low leucine content drink, high leucine content drink and low leucine + HMB drink in people with Fasting and Metabolism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein metabolism after 36 hours fasting receiving different nutritional supplements. (time frame: 3 control period followed by 4 hours of nutritional drink intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.