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Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

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?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04587076
Acronym
BOP
Enrollment
38
Registered
2020-10-14
Start date
2019-07-03
Completion date
2019-09-30
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastric Bypass, Gastric Sleeve

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.

Interventions

None listed

Sponsors

University Medicine Greifswald
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Therapy Adherence Across Groups of Socio-Economic StatusBaselineNumber of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.

Secondary

MeasureTime frameDescription
Therapy Adherence Across Age GroupsBaselineNumber of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across age groups.
Therapy Adherence Across SexesBaselineNumber of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across sexes.
Improvement of Deficiency SymptomsBaselineDetermination of improvement of deficiency symptoms through adequate supplementation after bariatric surgery
Body WeightBaselineDetermination of body weight measured in kilograms
Body HeightBaselineDetermination of body height measured in centimeters
Body Mass IndexBaselineDetermination of body mass index measured in kg/m\^2 (calculated from the values obtained for body weight and height)
Waist CircumferenceBaselineDetermination of waist circumference measured in centimeters
Hip CircumferenceBaselineDetermination of hip circumference measured in centimeters
Waist-to-Hip RatioBaselineDetermination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
Triceps Skinfold ThicknessBaselineDetermination of triceps skinfold thickness measured in millimeters
Upper Arm CircumferenceBaselineDetermination of upper arm circumference measured in centimeters
Fat Free MassBaselineDetermination of fat free mass measured by Bioelectrical Impedance Analysis (BIA)
Skeletal Muscle MassBaselineDetermination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
Fat MassBaselineDetermination of fat mass measured by Bioelectrical Impedance Analysis (BIA)
Total Body WaterBaselineDetermination of total body water measured by Bioelectrical Impedance Analysis (BIA)
Extracellular WaterBaselineDetermination of extracellular water measured by Bioelectrical Impedance Analysis (BIA)
Protein IntakeBaselineDetermination of protein intake assessed by 7-day dietary record
Muscle StrengthBaselineDetermination of muscle strength assessed by handgrip dynamometry
Systolic Blood PressureBaselineDetermination of systolic blood pressure in mmHg
Diastolic Blood PressureBaselineDetermination of diastolic blood pressure in mmHg
Physical ActivityBaselineDetermination 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
Energy IntakeBaselineDetermination of energy intake (kcal/d) assessed by 7-day dietary record
Fat IntakeBaselineDetermination of fat intake assessed by 7-day dietary record
Omega-3 Fatty Acid IntakeBaselineDetermination of omega-3 fatty acid intake assessed by 7-day dietary record
Omega-6 Fatty Acid IntakeBaselineDetermination of omega-6 fatty acid intake assessed by 7-day dietary record
Carbohydrate IntakeBaselineDetermination of carbohydrate intake assessed by 7-day dietary record
Dietary Fiber IntakeBaselineDetermination of dietary fiber intake assessed by 7-day dietary record
Sucrose IntakeBaselineDetermination of sucrose intake intake assessed by 7-day dietary record
Alcohol IntakeBaselineDetermination of alcohol intake intake assessed by 7-day dietary record
Diet QualityBaselineDetermination 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
Quality of Life AssessmentBaselineQuality of life was assessed by employment of the German Short Form-12 Questionnaire, with higher scores indicating better quality of life.
Intestinal MicrobiomeBaselineDetermination of intestinal microbiome composition in comparison to healthy control subjects
Phase AngleBaselineDetermination of phase angle measured by Bioelectrical Impedance Analysis (BIA)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026