Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery (BOP)

October 7, 2020 updated by: University Medicine Greifswald

Evaluation of Protein Intake, Vitamin, Mineral, and Trace Element Supplementation After Bariatric Surgery According to the German S3 Guidelines - What Effects do Age, Sex, and Socio-economic Status Have on Adherence?

Obesity is a chronic disease in which accumulation of excess body fat can result in impaired health. In cases of severe obesity, weight loss surgery can be necessary as a treatment. There are different forms of surgery but the common basic principle is to restrict food intake and decrease the absorption of food in the stomach and intestines. As a consequence, there is a higher risk of developing nutrient deficiency after surgery and supplementation of protein, vitamins, and minerals can be necessary. This study evaluates intakes of protein, vitamins, and minerals in patients with weight loss surgery and compares them to recommended intakes. Further, this study looks at the role of age, sex, and socioeconomic status in this context.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Obesity is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. These days, bariatric surgery is considered the most effective treatment of morbid obesity. In the last decade, the number of bariatric surgeries performed worldwide constantly increased. Common bariatric surgery procedures include gastric bypass, sleeve gastrectomy, adjustable gastric band, and biliopancreatic diversion with duodenal switch. After surgery, weight loss is induced by a reduced food volume the stomach can hold, malabsorption of nutrients, or by a combination of both mechanisms. In consequence, patients with bariatric surgery have an increased risk of developing nutrient deficiency. Therefore, guidelines recommend supplementation of critical nutrients, i.e. protein, vitamins, and minerals, after bariatric surgery. This study assesses intake of these nutrients in patients with bariatric surgery based on the recommendations provided by the German S3 Guideline Group on the Surgical Treatment of Obesity and Metabolic Diseases. In particular, this study assesses the association of therapy adherence with age, sex, and socioeconomic status.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were recruited at University Medicine Greifswald, a medical center with expertise in obesity Treatment located in Northeast Germany. Patients meeting the study's eligibilty criteria who attended their routine postoperative care visits after bariatric surgery were approached for study participation.

Description

Inclusion Criteria:

  • Sleeve gastrectomy (postoperative)
  • Roux-en-Y gastric Bypass (postoperative)
  • Postoperative period > 6 month

Exclusion Criteria:

  • Missing consent
  • Pregnancy
  • Malignant tumor
  • Implanted pacemaker
  • Any other serious primary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapy Adherence Across Groups of Socio-Economic Status
Time Frame: Baseline
Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapy Adherence Across Age Groups
Time Frame: Baseline
Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across age groups.
Baseline
Therapy Adherence Across Sexes
Time Frame: Baseline
Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across sexes.
Baseline
Improvement of Deficiency Symptoms
Time Frame: Baseline
Determination of improvement of deficiency symptoms through adequate supplementation after bariatric surgery
Baseline
Body Weight
Time Frame: Baseline
Determination of body weight measured in kilograms
Baseline
Body Height
Time Frame: Baseline
Determination of body height measured in centimeters
Baseline
Body Mass Index
Time Frame: Baseline
Determination of body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)
Baseline
Waist Circumference
Time Frame: Baseline
Determination of waist circumference measured in centimeters
Baseline
Hip Circumference
Time Frame: Baseline
Determination of hip circumference measured in centimeters
Baseline
Waist-to-Hip Ratio
Time Frame: Baseline
Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
Baseline
Triceps Skinfold Thickness
Time Frame: Baseline
Determination of triceps skinfold thickness measured in millimeters
Baseline
Upper Arm Circumference
Time Frame: Baseline
Determination of upper arm circumference measured in centimeters
Baseline
Fat Free Mass
Time Frame: Baseline
Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Skeletal Muscle Mass
Time Frame: Baseline
Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Fat Mass
Time Frame: Baseline
Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Total Body Water
Time Frame: Baseline
Determination of total body water measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Extracellular Water
Time Frame: Baseline
Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Phase Angle
Time Frame: Baseline
Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA)
Baseline
Muscle Strength
Time Frame: Baseline
Determination of muscle strength assessed by handgrip dynamometry
Baseline
Systolic Blood Pressure
Time Frame: Baseline
Determination of systolic blood pressure in mmHg
Baseline
Diastolic Blood Pressure
Time Frame: Baseline
Determination of diastolic blood pressure in mmHg
Baseline
Physical Activity
Time Frame: Baseline
Determination of metabolic equivalents of task per day and activity level assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form
Baseline
Energy Intake
Time Frame: Baseline
Determination of energy intake (kcal/d) assessed by 7-day dietary record
Baseline
Protein Intake
Time Frame: Baseline
Determination of protein intake assessed by 7-day dietary record
Baseline
Fat Intake
Time Frame: Baseline
Determination of fat intake assessed by 7-day dietary record
Baseline
Omega-3 Fatty Acid Intake
Time Frame: Baseline
Determination of omega-3 fatty acid intake assessed by 7-day dietary record
Baseline
Omega-6 Fatty Acid Intake
Time Frame: Baseline
Determination of omega-6 fatty acid intake assessed by 7-day dietary record
Baseline
Carbohydrate Intake
Time Frame: Baseline
Determination of carbohydrate intake assessed by 7-day dietary record
Baseline
Dietary Fiber Intake
Time Frame: Baseline
Determination of dietary fiber intake assessed by 7-day dietary record
Baseline
Sucrose Intake
Time Frame: Baseline
Determination of sucrose intake intake assessed by 7-day dietary record
Baseline
Alcohol Intake
Time Frame: Baseline
Determination of alcohol intake intake assessed by 7-day dietary record
Baseline
Diet Quality
Time Frame: Baseline
Determination of diety quality assessed by 7-day dietary record based on the Alternate Healthy Eating Index 2010 (AHEI-2010) score. Scores range from 0 to 110, with higher scores indicating higher diet quality
Baseline
Quality of Life Assessment
Time Frame: Baseline
Quality of life was assessed by employment of the German Short Form-12 Questionnaire, with higher scores indicating better quality of life.
Baseline
Intestinal Microbiome
Time Frame: Baseline
Determination of intestinal microbiome composition in comparison to healthy control subjects
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BB 080/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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