E78.0
Conditions
Interventions
Group 1: Intervention group:
Synbiotic combination of probiotic and dipeptide, 1 capsule daily for 12 weeks.
Group 2: Placebo group:
Placebo in capsule form, 1 capsule daily for 12 weeks
Sponsors
Evonik Operations GmbH
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males and females 2. 21 to 65 year sold 3. BMI 23–34.9kg/m2 4. Generally in good health 5. LDL-C level =130mg/dL =189mg/dL (=3.359mmol/L = 4.854 mmol/L) 6. Stable body weight for at least 3 months prior to study inclusion (<5 % weight change) (self-reported) 7. Electrocardiogram (ECG) without pathological findings at V1 8. Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit) 9. Readiness and ability to comply with study requirements, in particular: - to take IP as recommended - to accept the required blood draws - to avoid the use of any nutritional, medical and further interventional options for management of blood lipids and/or blood sugar and/or body weight during the study (other than the IP) - to keep the dietary and sleeping habits and the habitual level of physical activity during the study - to complete the subject diary and questionnaires 10.Women of childbearing potential: - commitment to use contraception methods - negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 11.Readiness not to participate in another clinical study during this study
Exclusion criteria
Exclusion criteria: 1.Known allergy or hypersensitivity to the components of the investigational product 2. Known genetic hyperlipidemia 3. History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: - cardiovascular disease/disorder - untreated or non-stabilised diabetes mellitus - untreated or non-stabilised thyroid gland disorder - untreated or non-stabilised hypertension (regular systolic blood pressure = 160 mmHg and/or dias- tolic blood pressure = 100 mmHg) acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) - immune deficiency or autoimmune disorder - acute or chronic psychotic disorder - eating disorder - any other relevant serious diseases 4. Relevant surgical procedure with in the last 6 months prior to V1 or planned during the study (e.g. GI surgery, liposuction etc.), as per investigator's judgement 5. Clinically significant deviation of screening laboratory parameter(s) at V1 6. Regular medication and/or supplementation and/or treatment (including any natural health products) within the last month prior to V1 and during the study, as per investigator judgement: - probiotics, prebiotics - proton pump inhibitors - lipid lowering products (known to affect lipid metabolism, platelet function, antioxidant status, etc.), in- cluding dietary or health supplements (e.g. omega- 3 fatty acids, oat fiber, plant sterols etc.) - products that can influence cholesterol levels (e.g. corticosteroids, beta blockers, estrogen, anabolic steroids), unless long term and stabilised use (contraceptives are allowed in case of a stable continuous intake before and during the study) - that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) - that could influence body weight (e.g. fat binder/ burner, carb blocker, satiety products, neuroleptics etc.) - that could influence glycemic control (e.g. metformin, acarbose etc.) - any other, which could interfere with the results of the study or the safety of the subject 7. Antibiotics within the last month prior to V1 and during the study 8. Any electronic medical implant 9. Smoking >10cigarettes/day at time of V1 and during the study 10. Strict Mediterranean, strict vegan or fibre-rich diet 11. Women of childbearing potential: pregnancy or nursing 12. History of or current abuse of drugs, alcohol or medication 13. Participation in another study during the last 30 days prior to V1 14. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in changes of values in lipid parameter LDL-C measured by blood analysis at visits V3 (4 weeks ±5 days after V2), V4 (8 weeks ±5 days after V2) and V5 (12 weeks ±5 days after V2) compared to baseline (V2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in values of lipid parameter LDL-C at V5 • Difference in values and changes of values of lipid parameter LDL-C from baseline (V2) to each V3 and V4 • Difference in values and difference in changes of values at V3, V4 and V5, each in comparison to baseline (V2), of: - Other lipid parameters (total cholesterine, HDL-C, triglyceride, non-HDL-C, LDL-C/HDL-C ratio) - Atherogenic index (AI), atherogenic coefficient (AC) and Systematic Coronary Risk Evaluation (SCORE) value - glycemic control parameters HbA1c, fasting glucose, fasting insulin - HOMA indices (HOMA-IR, HOMA-B) - blood inflammatory parameters (TNF-alpha, hsCRP) - body weight - Body Fat Mass (kg) and Body Fat Mass/body weight (%) - Waist Circumference, Hip Circumference and Waist Hip Ratio - SF-36 - Short Chain Fatty Acids in stool (butyric, acetic, propionic acid and total SCFA) • Difference in values and difference in changes of values at V5 in comparison to baseline (V2), of: - glycemic control parameter fructosamine stool gut permeability/inflammatory parameters (zonulin, alpha-1 an- titrypsin and calprotectin) SCFA in blood (butyric, acetic, propionic acid and total SCFA) - GLP-1, PYY • Global evaluation of benefit by the subject and investigator at study end | — |
Countries
Germany
Contacts
Public ContactLiana Vismane
analyze & realize GmbH Studienzentrum
Outcome results
None listed