J Food Bioact

Journal of Food Bioactives, ISSN 2637-8752 print, 2637-8779 online

Journal website www.isnff-jfb.com

Original Research

Volume 10, June 2020, pages 64-69

Evaluation of the hypo-allergenicity effect of rice and wheat hydrolysates: a double-blind randomized clinical trial

**Table 1.** Shows the baseline characteristics of all subjects
	Rice hydrolysate (RH)	Wheat hydrolysate (WH)
All the values are expressed as average ± standard error mean (SEM). *P value (p < 0.05; RH Vs WH) represented a statistically significant.
Sex (M/F)	13/27	5/5
Age (year-Maen)	6–72 (32)	8–52 (35)
Eosinophil count (mm³)	456.04 ± 90.50	433.50 ± 120.26*
ECP (µg/L)	20.26 ±6.32	21.35 ±6.39
Total IgE (IU/mL)	383.80 ± 46.47	403.54 ± 42.84*

Table 1. Shows the baseline characteristics of all subjects

Rice hydrolysate (RH)

Wheat hydrolysate (WH)

All the values are expressed as average ± standard error mean (SEM). *P value (p < 0.05; RH Vs WH) represented a statistically significant.

Sex (M/F)

13/27

5/5

Age (year-Maen)

6–72 (32)

8–52 (35)

Eosinophil count (mm³)

456.04 ± 90.50

433.50 ± 120.26*

ECP (µg/L)

20.26 ±6.32

21.35 ±6.39

Total IgE (IU/mL)

383.80 ± 46.47

403.54 ± 42.84*

**Table 2.** Shows the overall patient allergic score (based on questionnaires)
Weeks	Rice hydrolysate (RH)	Wheat hydrolysate (WH)
All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, b, c) were deemed as statistically significant. Allergic scale: 0 to 7, not Allergic; 8 to 12, maybe allergic; 12>, confirmed allergic.
Baseline (0 Week)	18.81 ± 8.24^a	21.50 ± 7.96^a
2^nd Week	18.56 ± 8.27^a	22.13 ± 7.04^a
4^th Week	16.67 ± 8.24^b	22.48 ± 6.45^a

Table 2. Shows the overall patient allergic score (based on questionnaires)

Weeks

Rice hydrolysate (RH)

Wheat hydrolysate (WH)

All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, b, c) were deemed as statistically significant. Allergic scale: 0 to 7, not Allergic; 8 to 12, maybe allergic; 12>, confirmed allergic.

Baseline (0 Week)

18.81 ± 8.24^a

21.50 ± 7.96^a

2^nd Week

18.56 ± 8.27^a

22.13 ± 7.04^a

4^th Week

16.67 ± 8.24^b

22.48 ± 6.45^a

**Table 3.** Shows the blood eosinophil and IgE count
Parameters	Weeks	Rice Hydrolysate (RH)	Wheat Hydrolysate (WH)
All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 4^th week). Value represented with different alphabetic superscript letters (a, b, c) were deemed as statistically significant.
Eosinophil count (mm³)	Baseline (0)	456.04 ± 19.50^a	433.50 ± 61.26^a
4^th Week	403.41 ± 12.05^b	450.50 ± 69.86^b
ECP (µg/L)	Baseline (0)	20.26 ± 6.32^a	21.35 ±6.39^a
4^th Week	17.43 ± 4.10^b	20.58 ± 2.04^a
Total IgE (IU/mL)	Baseline (0)	383.80 ± 46.47^a	403.54 ± 42.84^a
4^th Week	400.10 ± 45.21^a	421.82 ± 58.14^b

Table 3. Shows the blood eosinophil and IgE count

Parameters

Weeks

Rice Hydrolysate (RH)

Wheat Hydrolysate (WH)

All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 4^th week). Value represented with different alphabetic superscript letters (a, b, c) were deemed as statistically significant.

Eosinophil count (mm³)

Baseline (0)

456.04 ± 19.50^a

433.50 ± 61.26^a

4^th Week

403.41 ± 12.05^b

450.50 ± 69.86^b

ECP (µg/L)

Baseline (0)

20.26 ± 6.32^a

21.35 ±6.39^a

4^th Week

17.43 ± 4.10^b

20.58 ± 2.04^a

Total IgE (IU/mL)

Baseline (0)

383.80 ± 46.47^a

403.54 ± 42.84^a

4^th Week

400.10 ± 45.21^a

421.82 ± 58.14^b

**Table 4.** Shows the TNSS frequency and distress score
TNSS Examination	Weeks	Rice hydrolysate (RH)	Wheat hydrolysate (WH)
All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, ab, b, c) were deemed as statistically significant.
Total Frequency Score	Baseline (0 Week)	23.37 ± 15.65^a	25.88 ± 16.91^a
2^nd Week	21.96 ± 13.67^b	25.50 ± 17.86^a
4^th Week	18.44 ± 15.77^c	24.80 ± 17.93^a
Total degree of distress Score	Baseline (0 Week)	18.11 ± 16.50^b	21.38 ± 12.86^b
2^nd Week	16.89 ± 15.93^b	21.75 ± 14.01^b
4^th Week	14.41 ± 17.46^c	20.90 ± 17.88^b

Table 4. Shows the TNSS frequency and distress score

TNSS Examination

Weeks

Rice hydrolysate (RH)

Wheat hydrolysate (WH)

All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, ab, b, c) were deemed as statistically significant.

Total Frequency Score

Baseline (0 Week)

23.37 ± 15.65^a

25.88 ± 16.91^a

2^nd Week

21.96 ± 13.67^b

25.50 ± 17.86^a

4^th Week

18.44 ± 15.77^c

24.80 ± 17.93^a

Total degree of distress Score

Baseline (0 Week)

18.11 ± 16.50^b

21.38 ± 12.86^b

2^nd Week

16.89 ± 15.93^b

21.75 ± 14.01^b

4^th Week

14.41 ± 17.46^c

20.90 ± 17.88^b

**Table 5.** Shows the SCORAD Skin test scale
Weeks	Rice hydrolysate (RH)	Wheat hydrolysate (WH)
All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, ab, b, c) were deemed as statistically significant.
Baseline (0 Week)	99.10 ± 15.18^a	100.59 ± 17.15^a
2^nd Week	95.56 ± 12.20^a	86.10 ± 7.00^b
4^th Week	96.65 ± 11.75^a	55.93 ± 6.56^c

Table 5. Shows the SCORAD Skin test scale

Weeks

Rice hydrolysate (RH)

Wheat hydrolysate (WH)

All the values are expressed as average ± standard error mean (SEM). P value (p < 0.05; Baseline Vs 2^nd week Vs 4^th week). Value represented with different alphabetic superscript letters (a, ab, b, c) were deemed as statistically significant.

Baseline (0 Week)

99.10 ± 15.18^a

100.59 ± 17.15^a

2^nd Week

95.56 ± 12.20^a

86.10 ± 7.00^b

4^th Week

96.65 ± 11.75^a

55.93 ± 6.56^c