Table 4.
Characteristics of clinical trials in humans on the introduction of bread enriched with various physiological ingredients, and its effect, into the diet (n = 6).
| Jadad Scale |
Participants | Fortificant/Substance/ Dose/Inhibitor |
Duration | Methods/Analysis | Results | References/ Country |
|---|---|---|---|---|---|---|
| 3 | Diabetes patients N = 122 Age: 19–50+ BMI: 22.7–38.3 |
Phytochemicals/polyphenols; Borassus powder: (wheat flour: BRP; m:m) 2:1; 5:1; 10:1; 20:1 |
3 months | Venous blood, Physical parameters Visceral fat, Metabolic age SBP, DBP, TC |
waste reduction from 98.3 ± 14.6 cm to 95.9 ± 15.8 cm; BMI reduction by 3.4; visceral fat reduction from 10.4 ± 3.2 to 9.9 ± 3.0; metabolic age reduced from 61:6 ± 13:4 to 59:3 ± 13:0; SBP reduced from 161.2 ± 25.5 to 137.6 ± 22.9; DBP reduced from 99.2 ± 13.6 to 85.1 ± 10.8; TC reduced from 5.9 to 4.9; LDL reduced from 3.4 to 2.8; HDL reduced from 2.2 to 1.5 |
[35] Ghana |
| 0 | Diabetes patients Women N = 72 Age: 46–51 BMI: 35–37 |
Polyphenols; Turmeric powder: 10/100 g Ginger powder: 10/100 g |
8 weeks | Vein blood, Physical parameters (>10), CVD risk factors |
BMI reduction from 37 to 36, 35 to 34; BF reduction of 1–1.5%; TG reduction from 139.28 to 118 mg/dL, 135 to 102 mg/dL; TC from 234 to 205, 218 to 183; CVDrf decreased from 5.17 to 3.99, 4.73–3.63 |
[36] Egypt |
| 0 | Healthy adults N = 15 Age: 35–65 BMI: 21–32 |
Phenolic acids, Native ray bran: Ferulic acid—134 mg/portion; Sinapic acid—31 mg/portion; 4-Coumaric acid—4.7 mg/portion; Bioprocessed rye bran: Ferulic acid—117 mg/portion; Sinapic acid—28 mg/portion; 4-Coumaric acid—5 mg/portion |
24 h | Vein blood, Urine samples; Postprandial phenolic acid excretions, GR |
Bioprocessing of rye bran increased FA absorption by 14% vs. native rye bran | [37] Finland |
| 5 | Healthy adults N = 36, 39 Age: 18–70 BMI: <40 kg |
Phytosterols; Vegapure® 67WDP (BASF): 2.3g/2 slices; Curcumin: 228 mg/2 slices |
4 weeks | Venous blood, TC, LDL, CVD risk | TC decrease of 0.52 mmol/L; LDL decrease of 0.49 mmol/L–124.33 nmol/L; CVD risk decreased from 1.1 to 12.7% |
[38] Australia |
| 1 | Healthy adults N = 13 Age: 20–46 BMI: 19.4–29.7 |
Polyphenols; Green tea extract powder: 0.4% of loaf weight in g; Baobab fruit extract powder: 1.88% of loaf weight in g |
6 days | Vein blood, GR, IR, Satiety |
No statistically significant changes | [39] Australia |
| 5 | CVD risk patients N = 30 Age: 18–65 BMI: 23–31 |
Neurotransmitters, Enzyme inhibitors, γ-Aminobutyric acid: 22.8 mg/100 g; Angiotensin-converting enzyme inhibitor: 7.23 mg/g (LSBþG) |
112 days | Vein blood, Urine samples, BP, GM, Endothelial function |
BP decreased for 2.12 mmHg for LSBþG | [40] Spain |
Jadad scale—0–5, N—number of population, Age—years, BMI—body mass index (kg/m2), SBP—systolic blood pressure, DBP—diastolic blood pressure, BP—blood pressure, TC—serum total cholesterol, LDL—low-density lipoprotein cholesterol, HDL—high-density lipoprotein cholesterol, TG—triglyceride, GR—glycemic response, IR—insulin response, GM—glucose metabolism, BF—body fat, CVDrf—cardiovascular disease risk factor.