Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery (BOP)

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?

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Obesity, Morbid; Vitamin Deficiency; Protein Malnutrition; Trace Element Deficiency; Mineral Deficiency

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany
    • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Gastric Bypass; Gastric Sleeve
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Deficiency Diseases; Severe Acute Malnutrition; Obesity; Obesity, Morbid; Malnutrition; Avitaminosis; Kwashiorkor
• Other Study ID Numbers: BB 080/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No