Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

Completed

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

• Registration Number: NCT04587076
• Lead Sponsor: University Medicine Greifswald

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.

Study Timeline

• Study Start: 2019-07-03
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapy Adherence Across Groups of Socio-Economic Status	Baseline	Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across groups of socio-economic status.

Secondary Outcome Measures

Name	Time	Method
Body Weight	Baseline	Determination of body weight measured in kilograms
Waist Circumference	Baseline	Determination of waist circumference measured in centimeters
Total Body Water	Baseline	Determination of total body water measured by Bioelectrical Impedance Analysis (BIA)
Diastolic Blood Pressure	Baseline	Determination of diastolic blood pressure in mmHg
Therapy Adherence Across Age Groups	Baseline	Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across age groups.
Body Height	Baseline	Determination of body height measured in centimeters
Therapy Adherence Across Sexes	Baseline	Number of recommendations followed by the patients according to the recommendations provided by the German S3 Guidelines across sexes.
Improvement of Deficiency Symptoms	Baseline	Determination of improvement of deficiency symptoms through adequate supplementation after bariatric surgery
Body Mass Index	Baseline	Determination of body mass index measured in kg/m\^2 (calculated from the values obtained for body weight and height)
Hip Circumference	Baseline	Determination of hip circumference measured in centimeters
Waist-to-Hip Ratio	Baseline	Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
Triceps Skinfold Thickness	Baseline	Determination of triceps skinfold thickness measured in millimeters
Upper Arm Circumference	Baseline	Determination of upper arm circumference measured in centimeters
Phase Angle	Baseline	Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA)
Systolic Blood Pressure	Baseline	Determination of systolic blood pressure in mmHg
Energy Intake	Baseline	Determination of energy intake (kcal/d) assessed by 7-day dietary record
Protein Intake	Baseline	Determination of protein intake assessed by 7-day dietary record
Fat Intake	Baseline	Determination of fat intake assessed by 7-day dietary record
Omega-6 Fatty Acid Intake	Baseline	Determination of omega-6 fatty acid intake assessed by 7-day dietary record
Dietary Fiber Intake	Baseline	Determination of dietary fiber intake assessed by 7-day dietary record
Fat Free Mass	Baseline	Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA)
Fat Mass	Baseline	Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA)
Skeletal Muscle Mass	Baseline	Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
Extracellular Water	Baseline	Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA)
Muscle Strength	Baseline	Determination of muscle strength assessed by handgrip dynamometry
Physical Activity	Baseline	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
Carbohydrate Intake	Baseline	Determination of carbohydrate intake assessed by 7-day dietary record
Omega-3 Fatty Acid Intake	Baseline	Determination of omega-3 fatty acid intake assessed by 7-day dietary record
Sucrose Intake	Baseline	Determination of sucrose intake intake assessed by 7-day dietary record
Alcohol Intake	Baseline	Determination of alcohol intake intake assessed by 7-day dietary record
Diet Quality	Baseline	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
Quality of Life Assessment	Baseline	Quality of life was assessed by employment of the German Short Form-12 Questionnaire, with higher scores indicating better quality of life.
Intestinal Microbiome	Baseline	Determination of intestinal microbiome composition in comparison to healthy control subjects

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany