NCT00870259

Brief Summary

The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

March 26, 2009

Last Update Submit

December 3, 2014

Conditions

Obesity

Keywords

Weight lossWeight maintenance

Outcome Measures

Primary Outcomes (1)

  • Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline

    2, 6 and 12 months

Secondary Outcomes (3)

  • Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state

    week 8 vs week 10

  • Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety

    0, 2, 6 and 12 months

  • Association of psychosocial factors with successful weight maintenance

    12 months

Interventions

Optifast VLCDDIETARY_SUPPLEMENT

Meal replacement, three times daily for 8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males and post-menopausal females
  • aged over 18 years
  • BMI 27-40kg/m2
  • weight-stable

You may not qualify if:

  • major comorbid medial condition (including diabetes)
  • taking medications known to affect weight
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg Repatriation Hospital

Melbourne, Victoria, 3081, Australia

Location

Related Publications (1)

  • Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

    PMID: 22029981DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical research fellow

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

AU(1)