Fate of Nutrient-Derived Amino Acids, FONDAA

NCT ID: NCT02587156

Last Updated: 2018-03-05

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-08

Brief Summary

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12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.

Detailed Description

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Conditions

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Protein Utilization Dietary Protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Meal serving at high dietary protein

Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day

Group Type EXPERIMENTAL

Meal serving at high dietary protein

Intervention Type DIETARY_SUPPLEMENT

Participants are habituated to a high level of dietary protein intake for 21 days.

Meal serving

Intervention Type DIETARY_SUPPLEMENT

To investigate impact of habituated protein level

Meal serving at low dietary protein

Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day

Group Type ACTIVE_COMPARATOR

Meal serving at low dietary protein

Intervention Type DIETARY_SUPPLEMENT

Participants are habituated to a low level of dietary protein intake for 21 days.

Meal serving

Intervention Type DIETARY_SUPPLEMENT

To investigate impact of habituated protein level

Interventions

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Meal serving at high dietary protein

Participants are habituated to a high level of dietary protein intake for 21 days.

Intervention Type DIETARY_SUPPLEMENT

Meal serving at low dietary protein

Participants are habituated to a low level of dietary protein intake for 21 days.

Intervention Type DIETARY_SUPPLEMENT

Meal serving

To investigate impact of habituated protein level

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males age 65-70
* Independently dwelling
* Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
* Non-diabetic
* No organ disease
* No back pain
* Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
* Alcohol intake below 21 units pr. week
* No known arthrosclerosis

Exclusion Criteria

* Hyperlipidemia
* Hypertension
Minimum Eligible Age

65 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Grith Højfeldt

MSc. Human Biology - PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grith Højfeldt, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Lars Holm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Institute of Sports Medicine Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.

Reference Type DERIVED
PMID: 32710741 (View on PubMed)

Other Identifiers

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BBH122

Identifier Type: -

Identifier Source: org_study_id

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