Table 1.
Characteristics of clinical trials in humans regarding the introduction of mineral-fortified bread into their diet (n = 9).
| Jadad Scale |
Participants | Fortificant/Substance/ Dose/Inhibitor |
Duration | Methods/Analysis | Results | References/ Country |
|---|---|---|---|---|---|---|
| 1 | Young male adults; N = 11; Age: 18–30 BMI: 23.8–28.6 |
Potassium, Magnesium, Phosphorus; 3.6 g of MgCO3 and 12.5 g of KH2PO4/kg of flour; 7.2 g of MgCO3 and 25 g of KH2PO4/kg of flour |
30 days | Venous blood; PG; GR; IR; triacylglycerols; total P, Mg, and K; HOMA-IR |
TG and GR after consumption of fortified bread maintained at a lower level compared to control. | [14] Lebanon |
| 3 | Mother–child pairs; N = 22; Age: 18–45, 2.5–5. |
Iron; 2/4 mg of 57Fe as FeFum, 2/4 mg of NaFeEDTA (Na58FeEDTA and Na57FeEDTA); 2–4 mg/day (4 times during experiment) |
28 days | Venous blood, FIA, BIS |
FIA from NaFeEDTA is 40% higher than from FeFum; combination of both fortificants does not lead to a significant increase in FIA. | [15] Haiti |
| 1 | Women; N = 46; Age: 18–49; Anemic: Hb < 12 g/dL, Non-anemic: Hb ≥ 12 g/dL; BMI: 20.4–25.4 |
Iron; 6 mg of 57Fe as NaFeEDTA, 6 mg (3 mg/3 mg) of 58Fe/56Fe as NaFeEDTA; Tea |
17 days | Venous blood, FIA |
Fe from NaFeEDTA increases by 17% in the anemia-free group and 33% in the iron-deficient group; tea consumption reduced iron absorption (>85%) in both groups. NaFeEDTA cannot overcome the inhibition of tea polyphenols. | [16] Morocco |
| 1 | Mother–child pairs; N = 17; Age: 18–40, 2–6 BMI: 21.7–22.11. |
Iron; 2/4 mg of 58FeSO4, 2/4 mg of 57FeFum; Tea |
30 days | Venous blood, FAFe |
Fe absorbed from FeSO4 was 8.85% higher than for FeFum in mothers, and 56.36% in children. Tea reduced FAFe by 44–65%. | [17] Senegal |
| 0 | Women; N = 12; Age: 33–42 BMI: 25.8–30.1 |
Iron, Zinc; 58FeSO4, ZnSO4; Tea |
28 days | Venous blood, CI |
Fe absorption from the bread fortified with iron was 19.8% (10.5–37.2%); for 30 mg of Zn/kg, it was 18.5% (10.2–33.4%); 17.7% (7.7–38.7%) for 60 mg of Zn/kg; and 11.2% (6.2–20.3%) for 90 mg of Zn/kg. | [18] Chile |
| 3 | Children; N = 82; Age: 2–5. |
Iron, Processed amaranth |
6 months | Venous blood, hemoglobin, serum ferritin, CCR | Hemoglobin concentration in the amaranth group increased significantly from 112.1 to 120.3 compared to the control (106.9–113.2 g/L); anemia prevalence: CCR (CI:95%) decrease from 0.57 to 0.37 in amaranth group (μU/mL). | [19] Ethiopia |
| 0 | Healthy adults; N= 12; Age: 19.6–27.2 BMI: 19.9–24.7 |
Chromium; Cr-enriched yeast 500 μg of Cr/50 g of available carbohydrates |
4 weeks | Venous blood, PG, IR, GR, GI | GR after fortified bread was 101.27 mg/dL and 117.82 mg/dL, compared to control (128.46 mg/dL); GI of enriched breads was 34.22 and 62.35 while the control bread had GI = 100. | [21] Greece |
| 3 | Type 2 diabetes adults; N= 30; Age: 40–65 BMI: 27.9–31.1 |
Chromium; Cr-enriched yeast 99.0 μg of Cr/28 g of bread |
12 weeks | Venous blood, BMI, GR, IR |
Reduction in BMI from 29.3 to 28.9; decreased fasting plasma glucose from 143.2 to 129.6 (mg/dL); decrease of the mean glycosylated hemoglobin from 6.9 to 6.3 (%); decrease in fasting insulin from 6.8 to 4.4 (μU/mL). | [22] Greece |
| 0 | Healthy young adults; Type 2 diabetes adults; N= 10, 10; Age: 23–26, 43–65 BMI: 20–26.57 |
Chromium, Magnesium, Selenium; Wheat varieties; Cr: 14.0–15.2 μg/100 g Mg: 32.9–85.6 mg/100 g Se: 1.6–5.5 μg/100 g Buckwheat; Mg: 172 mg/100 g Se: 3.5 μg/100 g |
2 h | Vein blood, GI, PG |
Lower GI of Jizi439 by 19.67% and 10.78% (that of the mixture of white wheat and Chu20); the lowest PG in diabetes patients after Jizi439. |
[23] China |
Jadad scale—0–5, N—number of population, Age—years, BMI—body mass index (kg/m2), HOMA-IR–homeostasis model assessment of insulin resistance, PG—plasma glucose, P—phosphorus, Mg—magnesium, K—potassium, TG—total glucose, GR—glucose response, IR—insulin response, Fe—iron, FeFum—ferrous fumarate, NaFeEDTA—ethylenediaminetetraacetic acid ferric sodium salt, FIA/FAFe—fractional iron absorption, CI—circulating iron, GI—glycemic index, GR—glycemic response, BIS—body iron stores, Hb—hemoglobin, FIA/FAFe—fractional iron absorption, Zn—zinc, CCR—crude relative risk, CI—confidence interval, Cr—chromium.