Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethics
2.2. Study Design and Conduct
2.3. Subject Selection and Withdrawal
2.4. Inclusion Criteria
2.5. Exclusion Criteria
2.6. Test Products
2.6.1. Placebo
2.6.2. Probiotic Test Product
2.6.3. Synbiotic Test Product
2.6.4. Mode of Consumption
2.7. Assessments
2.7.1. Bioelectrical Impedance Analysis (BIA)
2.7.2. Visceral Adiposity Index (VAI)
2.7.3. Anthropometry
2.7.4. Blood Pressure
2.7.5. Serum Parameters
2.7.6. Sonography
2.7.7. Medication
2.7.8. Gastrointestinal Symptoms
2.7.9. Compliance
2.7.10. Adverse Events (AEs)
- Not related: No investigational product was taken, or the AE could be ascribed with reasonable certainty to another cause.
- Unlikely: There were good reasons to think that there was no relationship.
- Possible: Equally valid arguments could be considered for or against an implication of the study product.
- Probable: The relationship was likely.
- Certain (definitely): There was strong relationship.
2.8. Statistics
2.8.1. Determination of Sample Size
2.8.2. Definition of Sets to Be Analysed
Full Analysis Set (FAS)
- Violation of an essential and, before randomization, objectively measurable inclusion criterion.
- Not taking a single dose of the test substance (without knowledge of the assigned test group).
- Lack of any dates for the assessment of effectiveness after randomization.
Intention-To-Treat (ITT) Set
Per-Protocol (PP) Set
2.8.3. Statistical Tests
2.8.4. Definition of Primary, Secondary and Exploratory Data
2.8.5. Data Screening and Transformation
2.8.6. Approach to Treatment of Missing Values
2.8.7. Database Generation and Management
- The database was compiled after the last test person had completed the study.
- Data from paper documentation (CRFs, questionnaires) were transferred to electronic files by two persons each (double data entry), and the files were compared for discrepancies.
- Discrepancies between entries were corrected.
2.8.8. Interim Analysis
2.8.9. Software
3. Results
3.1. Key Data of Study Conduct
3.2. Study Populations
3.2.1. ITT Population
3.2.2. FAS Population
3.2.3. PP Population
3.3. Missing Values
3.4. Baseline Characteristics of the FAS Population
3.5. Alterations during Intervention
3.5.1. Body Composition as Assessed with Body Impedance Analysis (BIA) including Primary Parameter (Body Fat Mass (BFM))
3.5.2. Visceral Adiposity Index (VAI) According to Amato (Secondary Parameter)
3.5.3. Anthropometry and Blood Pressure
3.5.4. Laboratory Parameters
3.5.5. Sonography
3.5.6. Medication
3.5.7. Gastrointestinal Symptoms
3.5.8. Compliance
3.5.9. Adverse Events (AEs)
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Ingredients Per Sachet | Placebo | Probiotic | Synbiotic | ||
---|---|---|---|---|---|
CFU a.p. | CFU a.e.s. | CFU a.p. | CFU a.e.s. | ||
L. fermentum K7-Lb1 | 5 × 109 | 1 × 109 | 5 × 109 | 1 × 109 | |
L. fermentum K8-Lb1 | 5 × 109 | 1 × 109 | 5 × 109 CFU | 1 × 109 CFU | |
L. fermentum K11-Lb3 | 5 × 109 | 1 × 109 | 5 × 109 | 1 × 109 | |
mg | mg | mg | |||
Microcrystalline cellulose | 5555.6 | 5555.6 | |||
Acacia gum | 5555.6 | ||||
Sucralose | 11.3 | 11.3 | 11.3 | ||
Cream flavour | 97.4 | 97.4 | 97.4 | ||
Maltodextrin | 185.7 | 185.7 | 185.7 | ||
TOTAL | 6000.0 | 6000.0 | 6000.0 |
Time | Parameter | Mean | SD | Median | 25% | 75% |
---|---|---|---|---|---|---|
Point | ||||||
V0 | Age (years) | 60.06 | 12.33 | 62.00 | 53.00 | 69.00 |
Height (cm) | 170.1 | 9.1 | 170.0 | 163.3 | 176.0 | |
V1 | Weight (kg) | 93.83 | 17.82 | 92.30 | 80.46 | 102.20 |
BMI (kg/m2) | 32.33 | 5.45 | 30.84 | 28.42 | 34.87 | |
Waist (cm) | 109.45 | 12.36 | 107.5 | 101.05 | 115.30 | |
WHtR | 0.644 | 0.073 | 0.627 | 0.590 | 0.680 | |
Bp syst (mmHg) | 131.2 | 15.99 | 130.0 | 120.0 | 140.0 | |
Bp diast (mmHg) | 85.00 | 9.12 | 85.00 | 80.00 | 90.00 | |
Abs. BFM (kg) | 41.25 | 7.663 | 42.62 | 35.47 | 47.07 | |
Rel. BFM (%) | 38.94 | 11.72 | 35.62 | 31.76 | 46.04 | |
FFM (kg) | 54.89 | 11.36 | 52.55 | 45.31 | 64.20 | |
VAT(BIA) (L) | 4.208 | 2.13 | 3.595 | 2.82 | 5.072 | |
Glucose (mg/dL) | 110.3 | 17.58 | 107.0 | 101.0 | 117.0 | |
HbA1c (%) | 5.54 | 0.44 | 5.50 | 5.30 | 5.78 | |
HOMA-IR | 4.282 | 3.586 | 3.079 | 2.275 | 4.865 | |
QUICKI | 0.321 | 0.0276 | 0.323 | 0.303 | 0.337 | |
Cholesterol (mg/dL) | 227.8 | 44.23 | 225.5 | 195.3 | 257.5 | |
HDL-C (mg/dL) | 62.43 | 14.70 | 61.5 | 51.00 | 70.75 | |
LDL-C (mg/dL) | 146.0 | 33.38 | 141.5 | 124.0 | 164.75 | |
Triglycerides (mg/dL) | 129.1 | 56.86 | 118.0 | 87.0 | 162.0 | |
CRP | 0.395 | 0.742 | 0.23 | 0.13 | 0.46 | |
AST (U/L) | 26.48 | 9.255 | 24.0 | 21.0 | 29.0 | |
ALT (U/L) | 26.94 | 15.40 | 23.5 | 17.0 | 31.0 | |
GGT (U/L) | 31.11 | 23.39 | 24.0 | 17.0 | 34.0 | |
LSG | 1.148 | 0.637 | 1.00 | 0.67 | 1.67 | |
SAD | 52.21 | 23.12 | 50.55 | 33.4 | 69.93 |
(a) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Time Point | Param. | Group | Size | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
V0 | Age (years) | Pro | 60 | 61.50 | 11.30 | 63.00 | 56.30 | 69.80 | 0.016 | |
Syn | 60 | 56.90 | 14.60 | 59.00 | 48.00 | 68.00 | ||||
Pla | 60 | 61.80 | 10.30 | 63.50 | 54.30 | 70.00 | ||||
Height (cm) | Pro | 60 | 171.0 | 9.1 | 171.0 | 165.0 | 176.0 | 0.190 | ||
Syn | 60 | 168.0 | 8.3 | 169.0 | 162.0 | 174.0 | Normality | |||
Pla | 60 | 171.0 | 9.6 | 172.0 | 163.0 | 178.0 | (p ANOVA) | |||
V1 | Weight (kg) | Pro | 59 | 95.1 | 19.1 | 91.3 | 82.7 | 102.2 | 0.282 | |
Syn | 58 | 90.9 | 17.4 | 88.3 | 78.6 | 101.3 | ||||
Pla | 59 | 95.5 | 16.9 | 93.5 | 83.1 | 106.2 | ||||
BMI (kg/m2) | Pro | 59 | 32.37 | 5.18 | 31.07 | 28.90 | 34.80 | 0.612 | ||
Syn | 58 | 31.98 | 5.73 | 30.54 | 28.25 | 34.56 | ||||
Pla | 59 | 32.64 | 5.50 | 31.37 | 28.34 | 36.55 | ||||
Waist (cm) | Pro | 59 | 110.0 | 12.2 | 107.2 | 102.3 | 114.4 | 0.291 | ||
Syn | 58 | 107.6 | 12.8 | 105.8 | 97.5 | 115.1 | ||||
Pla | 59 | 110.7 | 12.1 | 108.3 | 101.5 | 119.0 | ||||
WHtR | Pro | 59 | 0.64 | 0.07 | 0.63 | 0.60 | 0.68 | 0.547 | ||
Syn | 58 | 0.64 | 0.08 | 0.62 | 0.59 | 0.67 | ||||
Pla | 59 | 0.65 | 0.08 | 0.64 | 0.60 | 0.71 | ||||
BP syst (mmHg) | Pro | 59 | 133.5 | 16.56 | 130.0 | 120.0 | 140.0 | 0.259 | ||
Syn | 58 | 128.6 | 17.09 | 130.0 | 118.8 | 140.0 | Normality | |||
Pla | 59 | 131.4 | 14.08 | 130.0 | 120.0 | 140.0 | (p ANOVA) | |||
BP diast (mmHg) | Pro | 59 | 86.4 | 9.51 | 90.0 | 80.0 | 90.0 | 0.426 | ||
Syn | 58 | 83.9 | 8.43 | 85.0 | 80.0 | 90.0 | ||||
Pla | 59 | 84.7 | 9.35 | 85.0 | 80.0 | 90.0 | ||||
BFM (kg) | Pro | 59 | 38.60 | 11.24 | 35.37 | 31.75 | 45.19 | 0.610 | ||
Syn | 58 | 38.44 | 12.34 | 34.67 | 31.64 | 47.00 | ||||
Pla | 59 | 39.78 | 11.70 | 38.27 | 31.38 | 47.19 | ||||
FFM (kg) | Pro | 59 | 56.47 | 12.77 | 54.85 | 45.26 | 66.24 | 0.190 | ||
Syn | 58 | 52.47 | 9.63 | 49.78 | 44.77 | 59.76 | ||||
Pla | 59 | 55.68 | 11.23 | 53.63 | 46.29 | 64.85 | ||||
VATBIA (L) | Pro | 59 | 4.45 | 2.27 | 3.72 | 3.00 | 5.30 | 0.123 | ||
Syn | 58 | 3.74 | 1.77 | 3.36 | 2.45 | 4.95 | ||||
Pla | 59 | 4.43 | 2.27 | 3.74 | 2.82 | 5.10 | ||||
SAD (mm) | Pro | 59 | 53.69 | 24.64 | 48.20 | 33.40 | 73.80 | 0.417 | ||
Syn | 58 | 49.01 | 22.68 | 43.60 | 29.80 | 66.18 | ||||
Pla | 59 | 53.87 | 22.03 | 54.90 | 37.60 | 71.70 | ||||
LSG | Pro | 59 | 1.31 | 0.70 | 1.33 | 0.67 | 1.78 | 0.120 | ||
Syn | 58 | 1.08 | 0.61 | 0.95 | 0.56 | 1.56 | ||||
Pla | 59 | 1.05 | 0.57 | 0.89 | 0.67 | 1.33 | ||||
(b) | ||||||||||
Time Point | Param. | Group | Size | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
V1 | Glucose (mg/dL) | Pro | 59 | 112.1 | 24.4 | 106.0 | 101.0 | 122.0 | 0.877 | |
Syn | 58 | 108.6 | 13.1 | 107.0 | 100.5 | 116.3 | ||||
Pla | 59 | 110.1 | 12.7 | 108.0 | 100.0 | 117.0 | ||||
HbA1c (%) | Pro | 59 | 5.58 | 0.40 | 5.60 | 5.30 | 5.80 | 0.353 | ||
Syn | 58 | 5.47 | 0.32 | 5.50 | 5.28 | 5.60 | ||||
Pla | 59 | 5.55 | 0.57 | 5.50 | 5.20 | 5.80 | ||||
HOMA-IR | Pro | 59 | 5.11 | 4.43 | 3.30 | 2.31 | 7.16 | 0.196 | ||
Syn | 58 | 4.03 | 3.76 | 2.83 | 2.19 | 4.45 | ||||
Pla | 59 | 3.71 | 2.05 | 3.09 | 2.29 | 4.53 | ||||
QUICKI | Pro | 59 | 0.316 | 0.030 | 0.320 | 0.289 | 0.337 | 0.164 | Normality | |
Syn | 58 | 0.325 | 0.030 | 0.327 | 0.307 | 0.339 | (p—ANOVA) | |||
Pla | 59 | 0.321 | 0.021 | 0.323 | 0.306 | 0.337 | ||||
Cholesterol (mg/dL) | Pro | 59 | 228.17 | 46.66 | 219.00 | 199.00 | 251.00 | 0.472 | ||
Syn | 58 | 232.72 | 44.82 | 228.00 | 198.25 | 265.00 | Normality | |||
Pla | 59 | 222.68 | 41.25 | 226.00 | 192.00 | 254.00 | (p-ANOVA) | |||
HDL-C (mg/dL) | Pro | 59 | 59.10 | 14.70 | 57.00 | 48.00 | 68.00 | 0.006 | Pro vs. Pla (p = 0.903) | |
Syn | 58 | 66.86 | 13.64 | 65.00 | 58.00 | 76.25 | Syn vs. Pla (p = 0.041) | |||
Pla | 59 | 61.41 | 14.86 | 60.00 | 52.00 | 70.00 | (Dunn’s method) | |||
LDL-C (mg/dL) | Pro | 59 | 148.66 | 34.65 | 142.00 | 128.00 | 166.00 | 0.530 | ||
Syn | 58 | 147.29 | 35.28 | 143.00 | 120.00 | 166.75 | ||||
Pla | 59 | 142.07 | 30.23 | 140.00 | 120.00 | 163.00 | ||||
Triglycerides (mg/dL) | Pro | 59 | 128.10 | 56.49 | 113.00 | 87.00 | 153.00 | 0.973 | ||
Syn | 58 | 128.16 | 51.08 | 120.00 | 90.00 | 167.25 | ||||
Pla | 59 | 130.98 | 63.19 | 119.00 | 87.00 | 164.00 | ||||
CRP (mg/L) | Pro | 59 | 0.52 | 1.21 | 0.23 | 0.16 | 0.47 | 0.136 | ||
Syn | 58 | 0.36 | 0.30 | 0.26 | 0.13 | 0.58 | ||||
Pla | 59 | 0.31 | 0.28 | 0.21 | 0.12 | 0.40 | ||||
AST (U/L) | Pro | 59 | 28.41 | 9.95 | 25.00 | 22.00 | 33.00 | 0.138 | ||
Syn | 58 | 25.83 | 9.82 | 24.00 | 19.00 | 28.25 | ||||
Pla | 59 | 25.20 | 7.66 | 24.00 | 20.00 | 28.00 | ||||
ALT (U/L) | Pro | 59 | 30.27 | 15.26 | 26.00 | 21.00 | 34.00 | 0.011 | Pro vs. Pla (p = 0.025) | |
Syn | 58 | 25.86 | 17.45 | 19.50 | 15.00 | 29.50 | Syn vs. Pla (p = 1.000) | |||
Pla | 59 | 24.66 | 12.89 | 23.00 | 16.00 | 28.00 | (Dunn’s method) | |||
GGT (U/L) | Pro | 59 | 32.48 | 20.96 | 27.00 | 20.00 | 37.00 | 0.142 | ||
Syn | 58 | 27.16 | 16.64 | 21.00 | 16.00 | 31.25 | ||||
Pla | 59 | 33.64 | 30.24 | 24.00 | 17.00 | 35.00 |
Time Period | Parameter | Group | Size | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
---|---|---|---|---|---|---|---|---|---|---|
∆(V3-V1) | BFM (kg) | Pro | 59 | −0.61 | 1.94 | −0.46 | −1.72 | 0.81 | 0.015 | Pro vs. Pla (p = 0.039) |
Syn | 58 | 0.24 | 1.52 | 0.30 | −0.79 | 0.95 | Syn vs. Pla (p = 0.730) | |||
Pla | 59 | 0.13 | 1.64 | 0.24 | −1.30 | 1.02 | Normality (Holm–Sidak) | |||
BFM (%) | Pro | 59 | −0.43 | 1.41 | −0.33 | −1.31 | 0.57 | 0.045 | Pro vs. Pla (p = 0.546) | |
Syn | 58 | 0.15 | 1.11 | 0.23 | −0.57 | 1.01 | Syn vs. Pla (p = 0.326) | |||
Pla | 59 | −0.05 | 1.11 | −0.10 | −1.03 | 0.70 | (Dunn’s method) | |||
FFM (kg) | Pro | 59 | −0.08 | 1.06 | −0.03 | −0.64 | 0.56 | 0.254 | ||
Syn | 58 | 0.01 | 1.19 | −0.14 | −0.91 | 0.74 | Normality | |||
Pla | 59 | 0.25 | 1.12 | 0.32 | −0.47 | 0.99 | ||||
VATBIA (L) | Pro | 59 | −0.20 | 0.44 | −0.19 | −0.44 | 0.04 | 0.021 | Pro vs. Pla (p = 0.148) | |
Syn | 58 | −0.02 | 0.39 | −0.03 | −0.15 | 0.15 | Syn vs. Pla (p = 0.675) | |||
Pla | 59 | −0.04 | 0.36 | −0.10 | −0.32 | 0.13 | (Dunn’s method) |
Time Period | Param. | Group | Size | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
---|---|---|---|---|---|---|---|---|---|---|
∆(V3-V1) | Weight (kg) | Pro | 59 | −0.69 | 2.17 | −0.60 | −1.90 | 0.75 | 0.013 | Pro vs. Pla (p = 0.012) |
Syn | 58 | 0.25 | 2.02 | 0.28 | −0.84 | 1.49 | Syn vs. Pla (p = 1.000) | |||
Pla | 59 | 0.37 | 1.87 | 0.10 | −0.60 | 1.80 | (Dunn’s method) | |||
BMI (kg/m2) | Pro | 59 | −0.24 | 0.74 | −0.20 | −0.65 | 0.27 | 0.013 | Pro vs. Pla (p = 0.011) | |
Syn | 58 | 0.08 | 0.70 | 0.10 | −0.32 | 0.51 | Syn vs. Pla (p = 1.000) | |||
Pla | 59 | 0.13 | 0.63 | 0.04 | −0.22 | 0.55 | (Dunn’s method) | |||
Waist (cm) | Pro | 59 | −1.57 | 2.70 | −1.80 | −3.00 | 0.00 | 0.016 | Pro vs. Pla (p = 0.033) | |
Syn | 58 | −0.53 | 2.57 | −0.45 | −1.83 | 1.00 | Syn vs. Pla (p = 1.000) | |||
Pla | 59 | −0.40 | 2.55 | −0.50 | −2.30 | 0.70 | (Dunn’s method) | |||
WHtR | Pro | 59 | −0.009 | 0.016 | −0.011 | −0.018 | 0.000 | 0.018 | Pro vs. Pla (p = 0.033) | |
Syn | 58 | −0.003 | 0.015 | −0.003 | −0.011 | 0.006 | Syn vs. Pla (p = 1.000) | |||
Pla | 59 | −0.002 | 0.015 | −0.003 | −0.013 | 0.004 | (Dunn’s method) | |||
BP syst (mmHg) | Pro | 58 | −1.93 | 14.64 | 0.00 | −10.00 | 5.00 | 0.414 | ||
Syn | 57 | −0.18 | 10.80 | 0.00 | −5.00 | 5.00 | ||||
Pla | 59 | −2.88 | 11.97 | 0.00 | −10.00 | 5.00 | ||||
BP diast (mmHg) | Pro | 58 | −3.22 | 8.05 | −5.00 | −6.75 | 0.00 | 0.049 | Pro vs. Pla (p = 0.243) | |
Syn | 57 | −0.83 | 6.52 | 0.00 | −5.00 | 5.00 | Syn vs. Pla (p = 0.845) | |||
Pla | 59 | −1.51 | 7.64 | 0.00 | −5.00 | 0.00 | (Dunn’s method) |
Time Period | Param. | Group | Size | Mean | SD | Median | 25% | 75% | p |
---|---|---|---|---|---|---|---|---|---|
∆(V3-V1) | Glucose (mg/dL) | Pro | 57 | −1.77 | 10.69 | −2.00 | −6.50 | 3.00 | 0.388 |
Syn | 57 | −1.75 | 8.08 | −2.00 | −6.00 | 3.00 | |||
Pla | 58 | −0.03 | 8.72 | −1.00 | −5.00 | 3.00 | |||
HbA1c (%) | Pro | 56 | −0.04 | 0.22 | 0.00 | −0.10 | 0.10 | 0.266 | |
Syn | 57 | 0.02 | 0.18 | 0.00 | −0.10 | 0.20 | |||
Pla | 58 | 0.01 | 0.24 | 0.00 | −0.10 | 0.13 | |||
Insulin (mU/L) | Pro | 57 | −2.45 | 7.80 | −1.60 | −4.05 | 2.00 | 0.164 | |
Syn | 57 | −0.30 | 6.41 | 0.00 | −2.40 | 2.40 | |||
Pla | 58 | −0.23 | 3.78 | −0.70 | −2.35 | 1.88 | |||
HOMA-IR | Pro | 57 | −0.77 | 2.88 | −0.42 | −1.15 | 0.54 | 0.164 | |
Syn | 57 | −0.16 | 2.06 | −0.11 | −0.58 | 0.59 | |||
Pla | 58 | −0.05 | 1.15 | −0.11 | −0.68 | 0.67 | |||
QUICKI | Pro | 57 | 0.004 | 0.022 | 0.008 | −0.003 | 0.014 | 0.283 | |
Syn | 57 | 0.000 | 0.018 | 0.002 | −0.010 | 0.013 | |||
Pla | 58 | 0.003 | 0.015 | 0.002 | −0.007 | 0.013 | |||
Cholesterol (mg/dL) | Pro | 57 | −3.11 | 24.97 | −6.00 | −16.00 | 14.50 | 0.653 | |
Syn | 57 | −6.58 | 24.53 | −4.00 | −19.00 | 6.00 | |||
Pla | 58 | −7.16 | 21.40 | −7.00 | −18.25 | 3.50 | |||
HDL Chol. (mg/dL) | Pro | 57 | 0.28 | 8.53 | 1.00 | −2.50 | 4.50 | 0.468 | |
Syn | 57 | −0.77 | 8.21 | 0.00 | −5.00 | 4.00 | |||
Pla | 58 | 0.72 | 6.51 | 1.00 | −3.00 | 4.25 | |||
LDL Chol. (mg/dL) | Pro | 57 | 2.02 | 20.10 | 2.00 | −8.00 | 16.00 | 0.416 | |
Syn | 57 | −0.65 | 19.63 | 0.00 | −9.50 | 10.50 | |||
Pla | 58 | −2.03 | 17.19 | −2.00 | −12.25 | 8.00 | |||
Triglycerides (mg/dL) | Pro | 57 | −8.16 | 47.12 | −1.00 | −27.50 | 17.00 | 0.353 | |
Syn | 57 | −15.33 | 45.66 | −10.00 | −30.50 | 6.00 | |||
Pla | 58 | −14.29 | 36.22 | −15.00 | −34.00 | 2.25 | |||
CRP (mg/L) | Pro | 57 | −0.18 | 1.24 | 0.00 | −0.11 | 0.04 | 0.626 | |
Syn | 57 | −0.01 | 0.28 | 0.00 | −0.09 | 0.06 | |||
Pla | 58 | 0.02 | 0.22 | 0.00 | −0.06 | 0.05 | |||
AST (U/L) | Pro | 57 | −0.12 | 13.00 | 0.00 | −4.00 | 2.50 | 0.137 | |
Syn | 57 | −0.60 | 6.63 | −1.00 | −4.00 | 2.00 | |||
Pla | 58 | 0.74 | 6.03 | 0.00 | −2.00 | 3.00 | |||
ALT (U/L) | Pro | 57 | −0.54 | 10.51 | 0.00 | −5.50 | 2.00 | 0.260 | |
Syn | 57 | 1.21 | 12.39 | 1.00 | −4.00 | 3.00 | |||
Pla | 58 | 1.72 | 9.75 | 1.00 | −2.00 | 4.00 | |||
GGT (U/L) | Pro | 57 | 0.97 | 17.88 | −1.00 | −3.50 | 2.00 | 0.812 | |
Syn | 57 | −0.49 | 5.90 | 0.00 | −2.00 | 1.50 | |||
Pla | 58 | 0.85 | 12.67 | −1.00 | −2.25 | 2.00 |
Time Period | Param. | Group | Size | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
---|---|---|---|---|---|---|---|---|---|---|
∆(V3-V1) | VATsono SAD (mm) | Pro | 57 | −6.28 | 9.34 | −5.30 | −10.85 | −1.20 | <0.001 | Pro vs. Pla (p < 0.001) |
Syn | 58 | −4.99 | 11.84 | −4.20 | −10.55 | 0.55 | Syn vs. Pla (p = 0.002) | |||
Pla | 59 | 2.06 | 11.65 | 3.40 | −6.10 | 9.90 | (Dunn’s method) | |||
LSG | Pro | 57 | −0.25 | 0.27 | −0.22 | −0.44 | −0.11 | <0.001 | Pro vs. Pla (p < 0.001) | |
Syn | 58 | −0.17 | 0.24 | −0.11 | −0.23 | 0.00 | Syn vs. Pla (p < 0.001) | |||
Pla | 59 | 0.05 | 0.29 | 0.00 | −0.11 | 0.22 | (Dunn’s method) |
Time Point | Parameter | Group | N | Mean | SD | Median | 25% | 75% | p | Post Hoc Test If Sign (vs. Control) |
---|---|---|---|---|---|---|---|---|---|---|
∆(V3-V1) | Total Score | Pro | 58 | −0.05 | 0.48 | −0.03 | −0.33 | 0.15 | 0.356 | |
Syn | 58 | −0.16 | 0.59 | −0.07 | −0.27 | 0.07 | ||||
Pla | 58 | −0.01 | 0.43 | 0.00 | −0.15 | 0.15 | ||||
Pain Score | Pro | 58 | 0.04 | 0.77 | 0.00 | 0.00 | 0.00 | 0.119 | ||
Syn | 58 | −0.16 | 0.62 | 0.00 | −0.33 | 0.00 | ||||
Pla | 58 | 0.05 | 0.46 | 0.00 | 0.00 | 0.00 | ||||
Reflux Score | Pro | 58 | −0.10 | 0.84 | 0.00 | 0.00 | 0.00 | 0.101 | ||
Syn | 58 | −0.24 | 0.53 | 0.00 | −0.50 | 0.00 | ||||
Pla | 58 | −0.05 | 0.79 | 0.00 | −0.50 | 0.00 | ||||
Indigestion Score | Pro | 58 | −0.15 | 0.88 | 0.00 | −0.56 | 0.25 | 0.544 | ||
Syn | 58 | −0.02 | 0.96 | 0.00 | −0.25 | 0.50 | ||||
Pla | 58 | −0.04 | 0.72 | 0.00 | −0.25 | 0.25 | ||||
Constipation Score | Pro | 58 | −0.10 | 0.89 | 0.00 | −0.33 | 0.00 | 0.012 | Syn vs. Pla (p = 0.014) (Dunn’s method) | |
Syn | 58 | −0.36 | 0.93 | 0.00 | −0.67 | 0.00 | ||||
Pla | 58 | 0.11 | 0.69 | 0.00 | 0.00 | 0.42 | ||||
Diarrhoea Score | Pro | 58 | 0.06 | 0.77 | 0.00 | −0.33 | 0.33 | 0.395 | ||
Syn | 58 | −0.10 | 0.87 | 0.00 | −0.33 | 0.08 | ||||
Pla | 58 | −0.12 | 0.76 | 0.00 | −0.33 | 0.33 |
Occurrence | Probiotic | Synbiotic | Placebo | p |
---|---|---|---|---|
UTI | 0 | 0 | 1 | 0.369 * |
GITI | 13 | 8 | 12 | 0.484 |
RTI | 4 | 6 | 8 | 0.478 |
Other infections | 4 | 5 | 6 | 0.804 |
Laboratory | 2 | 0 | 1 | 0.367 * |
Pain | 4 | 12 | 8 | 0.090 |
Allergy | 1 | 1 | 0 | 0.600 * |
Other AEs | 23 | 15 | 16 | 0.235 |
Total number of individuals with AEs | 34 | 32 | 33 | 0.963 |
Incidence | Probiotic | Synbiotic | Placebo | p |
UTI | 0 | 0 | 3 | 0.371 |
GITI | 15 | 11 | 16 | 0.512 |
RTI | 5 | 7 | 9 | 0.492 |
Other infections | 4 | 5 | 6 | 0.805 |
Laboratory | 2 | 0 | 1 | 0.369 |
Pain | 4 | 14 | 11 | 0.090 |
Allergy | 1 | 1 | 0 | 0.602 |
Other AEs | 33 | 19 | 22 | 0.180 |
Total number of AEs | 64 | 57 | 68 | 0.762 |
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Laue, C.; Papazova, E.; Pannenbeckers, A.; Schrezenmeir, J. Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study. Nutrients 2023, 15, 3039. https://doi.org/10.3390/nu15133039
Laue C, Papazova E, Pannenbeckers A, Schrezenmeir J. Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study. Nutrients. 2023; 15(13):3039. https://doi.org/10.3390/nu15133039
Chicago/Turabian StyleLaue, Christiane, Ekaterina Papazova, Angelika Pannenbeckers, and Jürgen Schrezenmeir. 2023. "Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study" Nutrients 15, no. 13: 3039. https://doi.org/10.3390/nu15133039