NCT03029572

Brief Summary

An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery. Subjects will be than randomized in 2 sub-groups: A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable obesity

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, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 14, 2017

Last Update Submit

January 19, 2017

Conditions

ObesityBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (8)

  • Vitamins A levels

    Change from Baseline at 6-months and 12-months post-RYGB

  • Vitamin E levels

    Change from Baseline at 6-months and 12-months post-RYGB

  • Selenium levels

    Change from Baseline at 6-months and 12-months post-RYGB

  • Zinc levels

    Change from Baseline at 6-months and 12-months post-RYGB

  • Copper levels

    Change from Baseline at 6-months and 12-months post-RYGB

  • Glutathione peroxidise

    Change from Baseline at 6-months and 12-months post-RYGB

  • Superoxide dismutase

    Change from Baseline at 6-months and 12-months post-RYGB

  • Iron levels

    Change from Baseline at 6-months and 12-months post-RYGB

Secondary Outcomes (15)

  • Total cholesterol

    6-months and 12-months post-RYGB

  • LDL-cholesterol

    6-months and 12-months post-RYGB

  • HDL-cholesterol

    6-months and 12-months post-RYGB

  • Triglycerides

    6-months and 12-months post-RYGB

  • Fasting glucose

    6-months and 12-months post-RYGB

  • +10 more secondary outcomes

Study Arms (2)

Standard diet

ACTIVE COMPARATOR

Standard healthy diet after RYGB surgery

Procedure: Bariatric surgery

Micro-nutriments' supplementation

EXPERIMENTAL

Healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation after RYGB surgery

Drug: Diet supplementationProcedure: Bariatric surgery

Interventions

Diet supplementationDRUG

Micronutriment supplementation therapy

Micro-nutriments' supplementation
Bariatric surgeryPROCEDURE

Roux-en-Y gastric bypass provided in both arms.

Micro-nutriments' supplementationStandard diet

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obesity BMI\>40 kg/m2

You may not qualify if:

  • Antidepressant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

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
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 24, 2017

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)