NCT02001636

Brief Summary

Obese patients, who underwent bariatric surgery, are at risk to develop protein malnutrition. The aim of this study is to evaluate the influence of postoperative protein supplementation on weight reduction, body composition and protein status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
Last Updated

December 5, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

November 20, 2013

Last Update Submit

November 27, 2013

Conditions

Protein Malnutrition

Keywords

Bariatric surgeryProtein malnutritionProtein supplementationBody compositionBody fat massProtein intake

Outcome Measures

Primary Outcomes (1)

  • Excess weight loss [%]

    At month 6

Secondary Outcomes (1)

  • Content of lean body mass in lost weight [%]

    At month 6

Other Outcomes (1)

  • Content of body fat in lost weight [%]

    At month 6

Study Arms (2)

Protein group

EXPERIMENTAL

Patient group which takes daily protein supplements after bariatric surgery over 6 months. Protein product: Resource Instant Protein 88, Nestlé Health Nutrition

Drug: Resource Instant Protein 88

Control group

PLACEBO COMPARATOR

Patient group which takes daily isocaloric placebo after bariatric surgery over 6 months and thus can be compared to the protein group. Placebo product: Resource Maltodextrin, Nestlé Health Nutrition

Drug: Resource Maltodextrin

Interventions

Resource Instant Protein 88DRUG

Protein product: Resource Instant Protein 88, Nestlé Health Nutrition; postoperative intake of 30 - 35 g powder per day over 6 months.

Protein group
Resource MaltodextrinDRUG

Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.

Control group

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • BMI of 35 kg/m2 or more
  • Indication for laparoscopic sleeve gastrectomy or Roux-en Y gastric bypass

You may not qualify if:

  • Renal disease
  • Type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Stephan C Bischoff, Prof.Dr.med.

    Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med. Stephan C. Bischoff

Study Record Dates

First Submitted

November 20, 2013

First Posted

December 5, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 5, 2013

Record last verified: 2013-11

Locations

DE(1)