NCT01366768

Brief Summary

The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

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

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

May 31, 2011

Last Update Submit

October 9, 2012

Conditions

Normal Non-fluency

Keywords

Gut hormonesInsulin secretionNormal physiology

Outcome Measures

Primary Outcomes (1)

  • Gut hormone secretion

    300 min

Secondary Outcomes (1)

  • Insulin secretion

    300 min

Study Arms (2)

Oral amino acid mixture

EXPERIMENTAL

Oral administration of amino acid mixture in healthy volunteers

Other: Oral amino acid mixture

Intravenous amino acid administration

EXPERIMENTAL

Intravenous infusion of amino acid mixture in healthy volunteers

Other: Intravenous amino acid administration

Interventions

Oral amino acid mixtureOTHER

Amino acid mixture 2,93 ml/kg

Also known as: Amino acid mixture
Oral amino acid mixture
Intravenous amino acid administrationOTHER

Amino acid mixture 2,93 ml/kg

Also known as: Amino acid mixture
Intravenous amino acid administration

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Diabetes
  • Liver disease
  • Kidney disease
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Sciences Lund, Lund University

Lund, 221 84, Sweden

Location

Study Officials

  • Bo Ahrén, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 6, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

SE(1)