Skip to main content
OpenTrials
Completed

NCT Number: NCT04587076

Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Protein Malnutrition Avitaminosis Body Weight Deficiency Diseases Kwashiorkor Malnutrition Mineral Deficiency Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Severe Acute Malnutrition Signs and Symptoms Trace Element Deficiency Vitamin Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Greifswald

Greifswald, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Improvement of Deficiency Symptoms

    Time frame: Baseline

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

  4. Body Weight

    Time frame: Baseline

    Determination of body weight measured in kilograms

  5. Body Height

    Time frame: Baseline

    Determination of body height measured in centimeters

  6. 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)

  7. Waist Circumference

    Time frame: Baseline

    Determination of waist circumference measured in centimeters

  8. Hip Circumference

    Time frame: Baseline

    Determination of hip circumference measured in centimeters

  9. Waist-to-Hip Ratio

    Time frame: Baseline

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

  10. Triceps Skinfold Thickness

    Time frame: Baseline

    Determination of triceps skinfold thickness measured in millimeters

  11. Upper Arm Circumference

    Time frame: Baseline

    Determination of upper arm circumference measured in centimeters

  12. Fat Free Mass

    Time frame: Baseline

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

  13. Skeletal Muscle Mass

    Time frame: Baseline

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

  14. Fat Mass

    Time frame: Baseline

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

  15. Total Body Water

    Time frame: Baseline

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

  16. Extracellular Water

    Time frame: Baseline

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

  17. Phase Angle

    Time frame: Baseline

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

  18. Muscle Strength

    Time frame: Baseline

    Determination of muscle strength assessed by handgrip dynamometry

  19. Systolic Blood Pressure

    Time frame: Baseline

    Determination of systolic blood pressure in mmHg

  20. Diastolic Blood Pressure

    Time frame: Baseline

    Determination of diastolic blood pressure in mmHg

  21. 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

  22. Energy Intake

    Time frame: Baseline

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

  23. Protein Intake

    Time frame: Baseline

    Determination of protein intake assessed by 7-day dietary record

  24. Fat Intake

    Time frame: Baseline

    Determination of fat intake assessed by 7-day dietary record

  25. Omega-3 Fatty Acid Intake

    Time frame: Baseline

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

  26. Omega-6 Fatty Acid Intake

    Time frame: Baseline

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

  27. Carbohydrate Intake

    Time frame: Baseline

    Determination of carbohydrate intake assessed by 7-day dietary record

  28. Dietary Fiber Intake

    Time frame: Baseline

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

  29. Sucrose Intake

    Time frame: Baseline

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

  30. Alcohol Intake

    Time frame: Baseline

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

  31. 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

  32. 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.

  33. Intestinal Microbiome

    Time frame: Baseline

    Determination of intestinal microbiome composition in comparison to healthy control subjects

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study 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?

Acronym: BOP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.