Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

Obesity Clinical Trial

— BOP  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587076
• Other study ID #: BB 080/19
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2020
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Kwashiorkor
• Malnutrition
• Mineral Deficiency
• Obesity
• Obesity, Morbid
• Protein Malnutrition
• Trace Element Deficiency
• Vitamin Deficiency

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

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