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Protein MalnutritionBOPNCT04587076

Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

An observational study of Protein Malnutrition and Vitamin Deficiency, run by University Medicine Greifswald at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
38 participants
Where
1 siteGermany
Study dates
3 Jul 2019to 30 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medicine Greifswald

    Greifswald

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
Gastric Bypass, Gastric Sleeve
Medical subject headings
Kwashiorkor, Avitaminosis, Obesity, Obesity, Morbid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapy Adherence Across Groups of Socio-Economic Status

    Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.

    Measured: Baseline

Secondary outcomes (33)

  1. Therapy Adherence Across Age Groups

    Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across age groups.

    Measured: Baseline

  2. Therapy Adherence Across Sexes

    Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across sexes.

    Measured: Baseline

  3. Improvement of Deficiency Symptoms

    Determination of improvement of deficiency symptoms through adequate supplementation after bariatric surgery

    Measured: Baseline

  4. Body Weight

    Determination of body weight measured in kilograms

    Measured: Baseline

  5. Body Height

    Determination of body height measured in centimeters

    Measured: Baseline

  6. Body Mass Index

    Determination of body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)

    Measured: Baseline

  7. Waist Circumference

    Determination of waist circumference measured in centimeters

    Measured: Baseline

  8. Hip Circumference

    Determination of hip circumference measured in centimeters

    Measured: Baseline

  9. Waist-to-Hip Ratio

    Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)

    Measured: Baseline

  10. Triceps Skinfold Thickness

    Determination of triceps skinfold thickness measured in millimeters

    Measured: Baseline

  11. Upper Arm Circumference

    Determination of upper arm circumference measured in centimeters

    Measured: Baseline

  12. Fat Free Mass

    Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  13. Skeletal Muscle Mass

    Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  14. Fat Mass

    Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  15. Total Body Water

    Determination of total body water measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  16. Extracellular Water

    Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  17. Phase Angle

    Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline

  18. Muscle Strength

    Determination of muscle strength assessed by handgrip dynamometry

    Measured: Baseline

  19. Systolic Blood Pressure

    Determination of systolic blood pressure in mmHg

    Measured: Baseline

  20. Diastolic Blood Pressure

    Determination of diastolic blood pressure in mmHg

    Measured: Baseline

  21. Physical Activity

    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

    Measured: Baseline

  22. Energy Intake

    Determination of energy intake (kcal/d) assessed by 7-day dietary record

    Measured: Baseline

  23. Protein Intake

    Determination of protein intake assessed by 7-day dietary record

    Measured: Baseline

  24. Fat Intake

    Determination of fat intake assessed by 7-day dietary record

    Measured: Baseline

  25. Omega-3 Fatty Acid Intake

    Determination of omega-3 fatty acid intake assessed by 7-day dietary record

    Measured: Baseline

  26. Omega-6 Fatty Acid Intake

    Determination of omega-6 fatty acid intake assessed by 7-day dietary record

    Measured: Baseline

  27. Carbohydrate Intake

    Determination of carbohydrate intake assessed by 7-day dietary record

    Measured: Baseline

  28. Dietary Fiber Intake

    Determination of dietary fiber intake assessed by 7-day dietary record

    Measured: Baseline

  29. Sucrose Intake

    Determination of sucrose intake intake assessed by 7-day dietary record

    Measured: Baseline

  30. Alcohol Intake

    Determination of alcohol intake intake assessed by 7-day dietary record

    Measured: Baseline

  31. Diet Quality

    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

    Measured: Baseline

  32. Quality of Life Assessment

    Quality of life was assessed by employment of the German Short Form-12 Questionnaire, with higher scores indicating better quality of life.

    Measured: Baseline

  33. Intestinal Microbiome

    Determination of intestinal microbiome composition in comparison to healthy control subjects

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start3 Jul 2019
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587076
Sponsor's protocol ID
BB 080/19
Acronym
BOP
Status last verified
Oct 2020
First submitted
7 Oct 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Protein Malnutrition and Vitamin Deficiency, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapy Adherence Across Groups of Socio-Economic Status (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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