Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Protein Malnutrition, Vitamin Deficiency, Mineral Deficiency, Trace Element Deficiency, Obesity, Obesity, Morbid

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| Therapy Adherence Across Sexes | Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across sexes. | Baseline | 
| Improvement of Deficiency Symptoms | Determination of improvement of deficiency symptoms through adequate supplementation after bariatric surgery | Baseline | 
| Body Weight | Determination of body weight measured in kilograms | Baseline | 
| Body Height | Determination of body height measured in centimeters | Baseline | 
| Body Mass Index | Determination of body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height) | Baseline | 
| Waist Circumference | Determination of waist circumference measured in centimeters | Baseline | 
| Hip Circumference | Determination of hip circumference measured in centimeters | Baseline | 
| Waist-to-Hip Ratio | Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) | Baseline | 
| Triceps Skinfold Thickness | Determination of triceps skinfold thickness measured in millimeters | Baseline | 
| Upper Arm Circumference | Determination of upper arm circumference measured in centimeters | Baseline | 
| Fat Free Mass | Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Skeletal Muscle Mass | Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Fat Mass | Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Total Body Water | Determination of total body water measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Extracellular Water | Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Phase Angle | Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA) | Baseline | 
| Muscle Strength | Determination of muscle strength assessed by handgrip dynamometry | Baseline | 
| Systolic Blood Pressure | Determination of systolic blood pressure in mmHg | Baseline | 
| Diastolic Blood Pressure | Determination of diastolic blood pressure in mmHg | Baseline | 
| 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 | Baseline | 
| Energy Intake | Determination of energy intake (kcal/d) assessed by 7-day dietary record | Baseline | 
| Protein Intake | Determination of protein intake assessed by 7-day dietary record | Baseline | 
| Fat Intake | Determination of fat intake assessed by 7-day dietary record | Baseline | 
| Omega-3 Fatty Acid Intake | Determination of omega-3 fatty acid intake assessed by 7-day dietary record | Baseline | 
| Omega-6 Fatty Acid Intake | Determination of omega-6 fatty acid intake assessed by 7-day dietary record | Baseline | 
| Carbohydrate Intake | Determination of carbohydrate intake assessed by 7-day dietary record | Baseline | 
| Dietary Fiber Intake | Determination of dietary fiber intake assessed by 7-day dietary record | Baseline | 
| Sucrose Intake | Determination of sucrose intake intake assessed by 7-day dietary record | Baseline | 
| Alcohol Intake | Determination of alcohol intake intake assessed by 7-day dietary record | Baseline | 
| 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 | Baseline | 
| 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. | Baseline | 
| Intestinal Microbiome | Determination of intestinal microbiome composition in comparison to healthy control subjects | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Bypass, Gastric Sleeve