NCT05291741

Brief Summary

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

First Submitted

Initial submission to the registry

February 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 5, 2026

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

February 21, 2022

Last Update Submit

April 29, 2026

Conditions

Bariatric Surgery CandidateVery Low Calorie DietWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    8 weeks

Secondary Outcomes (5)

  • Patient quality of life measured using the Short Form-12 (SF-12) questionnaire

    8 weeks and 1 year

  • Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose

    30 days after surgery

  • Use of health care services assessed by a medical chart review

    30 days after surgery

  • Severity of complications assessed by a medical chart review.

    30 days after surgery

  • Presence of eating disorders

    At baseline

Study Arms (2)

Very Low Calorie Diet (VLCD)

ACTIVE COMPARATOR

VLCD

Dietary Supplement: VLCD

Standard care

PLACEBO COMPARATOR

Standard care

Dietary Supplement: Standard care

Interventions

VLCDDIETARY_SUPPLEMENT

Advice regarding VLCD

Very Low Calorie Diet (VLCD)
Standard careDIETARY_SUPPLEMENT

Standard dietary advice for weight loss before bariatric surgery

Standard care

Eligibility Criteria

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

You may qualify if:

  • Eligible for bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Denmark

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 23, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 5, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)