Clinical trial NCT04587076: Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery
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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Protein Malnutrition
Vitamin Deficiency
Mineral Deficiency
Trace Element Deficiency
Obesity
Obesity, Morbid
Keywords: Gastric Bypass
Gastric Sleeve
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Therapy Adherence Across Groups of Socio-Economic Status
timeFrame: Baseline
Secondary outcomes:
measure: Therapy Adherence Across Age Groups
timeFrame: Baseline
measure: Therapy Adherence Across Sexes
timeFrame: Baseline
measure: Improvement of Deficiency Symptoms
timeFrame: Baseline
measure: Body Weight
timeFrame: Baseline
measure: Body Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Waist Circumference
timeFrame: Baseline
measure: Hip Circumference
timeFrame: Baseline
measure: Waist-to-Hip Ratio
timeFrame: Baseline
measure: Triceps Skinfold Thickness
timeFrame: Baseline
measure: Upper Arm Circumference
timeFrame: Baseline
measure: Fat Free Mass
timeFrame: Baseline
measure: Skeletal Muscle Mass
timeFrame: Baseline
measure: Fat Mass
timeFrame: Baseline
measure: Total Body Water
timeFrame: Baseline
measure: Extracellular Water
timeFrame: Baseline
measure: Phase Angle
timeFrame: Baseline
measure: Muscle Strength
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
measure: Energy Intake
timeFrame: Baseline
measure: Protein Intake
timeFrame: Baseline
measure: Fat Intake
timeFrame: Baseline
measure: Omega-3 Fatty Acid Intake
timeFrame: Baseline
measure: Omega-6 Fatty Acid Intake
timeFrame: Baseline
measure: Carbohydrate Intake
timeFrame: Baseline
measure: Dietary Fiber Intake
timeFrame: Baseline
measure: Sucrose Intake
timeFrame: Baseline
measure: Alcohol Intake
timeFrame: Baseline
measure: Diet Quality
timeFrame: Baseline
measure: Quality of Life Assessment
timeFrame: Baseline
measure: Intestinal Microbiome
timeFrame: Baseline
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Prof. Dr. med. Markus M. Lerch
role: PRINCIPAL_INVESTIGATOR
References: