NCT01366781

Brief Summary

The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Typical duration 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

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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

May 31, 2011

Last Update Submit

September 29, 2014

Conditions

Normal Non-fluency

Keywords

Gut hormonesInsulin secretion

Outcome Measures

Primary Outcomes (1)

  • Release of gut hormones

    300 min

Secondary Outcomes (1)

  • Insulin secretion

    300 min

Study Arms (2)

Healthy males

EXPERIMENTAL

Meal ingestion in healthy males

Other: Meal ingestion

Healthy females

EXPERIMENTAL

Meal ingestion in healthy females

Other: Meal ingestion

Interventions

Meal ingestionOTHER

Meal 511 kcal, meal 743 kcal or meal 1034 kcal

Healthy femalesHealthy males

Eligibility Criteria

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

You may qualify if:

  • Healthy status

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

Related Publications (1)

  • Alsalim W, Omar B, Pacini G, Bizzotto R, Mari A, Ahren B. Incretin and islet hormone responses to meals of increasing size in healthy subjects. J Clin Endocrinol Metab. 2015 Feb;100(2):561-8. doi: 10.1210/jc.2014-2865. Epub 2014 Nov 6.

    PMID: 25375983DERIVED

Study Officials

  • Bo Ahrén, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
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

February 1, 2014

Study Completion

June 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

SE(1)