Effect of SophorOx^® on Oxidative Stress and Body Composition in Individuals with High BMI: A Randomized Controlled Trial

Figures & data

Table 1 Investigational Product Composition

Study Product	Active Ingredients	Percentage	Total Composition
LN-OS-22	Quercetin	51.7%	94.81%
	Rutin	40.75%
	Kaempferol	0.88%
	Isorhamnetin	1.33%
	Genistin	0.14%
	Genistein	0.005%
Placebo	Maltodextrin	100%	100%

Figure 1 Study flow chart.

Abbreviation: n; number of participants.

Figure 2 Participant Disposition.

Abbreviation: n; number of participants,

Table 2 Demographics and Baseline Characteristics of Randomized Participants

Parameters	Categories	LN-OS-22	Placebo	Total	*p-value
		(N=33)	(N=35)	(N=68)
Age (Years)	Mean	42.85 (7.42)	40.57 (5.91)	41.68 (6.73)	0.1652 (T)
	(Min, Max)	(31.00, 57.00)	(31.00, 52.00)	(31.00, 57.00)
Gender	Male	10 (30.30%)	12 (34.29%)	22 (32.35%)	0.7257 (C)
	Female	23 (69.70%)	23 (65.71%)	46 (67.65%)
Height (cm)	Mean	158.34 (7.96)	157.83 (8.98)	158.08 (8.44)	0.8065 (T)
	(Min, Max)	(143.06, 179.31)	(140.85, 175.00)	(140.85, 179.31)
Weight (kg)	Mean	75.66 (8.89)	76.07 (10.47)	75.87 (9.66)	0.8644 (T)
	(Min, Max)	(57.80, 98.00)	(60.00, 102.30)	(57.80, 102.30)
BMI (kg/m^2)	Mean	30.14 (2.84)	30.36 (2.64)	30.25 (2.72)	0.7390 (T)
	(Min, Max)	(25.68, 34.51)	(25.48, 34.82)	(25.48, 34.82)

Notes: *p values were calculated using two sample t-test (T) for continuous variables and Chi Square (C) test for categorical variables. Percentages were calculated using respective column header count as denominator.

Abbreviations: SD; standard deviation, N; number of participants.

Table 3 Summary of 8-Isoprostane Levels of the mITT Population

Parameters	Visit	LN-OS-22 (N=23)		Placebo (N=28)		p value^$
		Mean (SD)	95% CI	Mean (SD)	95% CI
8-Isoprostane (pg/mL)	Day 0	102.41 (60)	(76.46, 128.35)	175.26 (218.87)	(90.39, 260.13)	0.1016 (T)
	Day 56	109.03 (73.72)	(77.16, 140.91)	216.33 (205.7)	(136.56, 296.09)	0.0147 (T)
	Change from baseline at day 56	6.63 (85.19)	(−30.21, 43.47)	41.07 (115.64)	(−3.77, 85.91)
	p value^#	0.0222 (A)
	p value*	0.7126 (T)		0.0710 (T)

Notes: ^$p-value was calculated using two sample t-test (T). *p-values were calculated using paired t-test (T). ^#p-values were calculated using ANCOVA with treatment as factor and baseline value, age and BMI as covariate vs placebo.

Abbreviations: CI; confidence interval, N; number of participants, mITT; modified intention to treat, SD; standard deviation.

Table 4 Summary of Anthropometric Measurements of the mITT Population

Parameters	Visit	LN-OS-22 (N=23)		Placebo (N=28)		p value^$
		Mean (SD)	95% CI	Mean (SD)	95% CI
Body Weight (kgs)	Day 0	77.25 (7.24)	(74.12, 80.38)	75.99 (10.74)	(71.82, 80.15)	0.6317 (T)
	Day 56	75.18 (7.1)	(72.11, 78.25)	76.12 (10.58)	(72.02, 80.23)	0.7169 (T)
	Change from baseline at day 56	−2.07 (1.62)	(−2.77, −1.37)	0.14 (1.53)	(−0.45, 0.73)
	p value^#	<0.0001 (A)
	p value*	<0.0001 (T)		0.6339 (T)
Waist circumference (cm)	Day 0	103.16 (7.3)	(100.00, 106.32)	102.53 (7.94)	(99.45, 105.61)	0.7706 (T)
	Day 56	100.58 (6.85)	(97.62, 103.54)	102.22 (7.55)	(99.29, 105.15)	0.4264 (T)
	Change from baseline at day 56	−2.58 (1.69)	(−3.31, −1.85)	−0.31 (1.71)	(−0.98, 0.35)
	p value^#	<0.0001 (A)
	p value*	<0.0001 (T)		0.3457 (T)
Waist to height ratio	Day 0	0.65 (0.06)	(0.62, 0.68)	0.65 (0.04)	(0.63, 0.67)	0.8763 (T)
	Day 56	0.63 (0.06)	(0.61, 0.66)	0.65 (0.04)	(0.63, 0.66)	0.2995 (T)
	Change from baseline at day 56	−0.02 (0.01)	(−0.02, −0.01)	0 (0.01)	(−0.01, 0.00)
	p value^#	0.0005 (A)
	p value*	<0.0001 (T)		0.1018 (T)
BMI (kg/m^2)	Day 0	30.45 (2.71)	(29.28, 31.62)	30.44 (2.69)	(29.39, 31.48)	0.9888 (T)
	Day 56	29.65 (2.88)	(28.40, 30.89)	30.5 (2.62)	(29.48, 31.51)	0.2759 (T)
	Change from baseline at day 56	−0.8 (0.61)	(−1.06, −0.54)	0.06 (0.6)	(−0.17, 0.29)
	p value^#	<0.0001 (A)
	p value*	<0.0001 (T)		0.5984 (T)

Notes: ^$p-value was calculated using two sample t-test (T). *p-values were calculated using paired t-test (T). ^#p-values were calculated using ANCOVA with treatment as factor and baseline value, age and BMI as covariate vs placebo.

Abbreviations: BMI, body mass index, CI; confidence interval, mITT; modified intention to treat, N; number of participants SD; standard deviation.

Table 5 Summary of Inflammatory and Lipid Peroxidation Biomarkers of the mITT Population

Parameters	Visit	LN-OS-22 (N=23)		Placebo (N=28)				p value^$
		Mean (SD)	95% CI	Mean (SD)			95% CI
CRP (mg/L)	Day 0	5.63 (6.17)	(2.96, 8.30)	5.75 (5.39)			(3.65, 7.84)	0.9433 (T)
	Day 56	6.3 (9.18)	(2.33, 10.27)	7.45 (7.03)			(4.72, 10.17)	0.6157 (T)
	Change from baseline at day 56	0.67 (9.92)	(−3.62, 4.96)	1.7 (6.17)			(−0.69, 4.10)
	p value^#	0.8116 (A)
	p value*	0.7481 (T)		0.1557 (T)
IL-6 (pg/mL)	Day 0	7.03 (9.49)	(2.93, 11.14)	77.45 (374.07)			(−67.60, 222.50)	0.3282 (T)
	Day 56	7.5 (5.74)	(5.02, 9.98)	13.03 (18.16)			(5.99, 20.07)	0.1374 (T)
	Change from baseline at day 56	0.46 (11.89)	(−4.68, 5.60)	−64.42 (376.76)			(−210.51, 81.67)
	p value^#	0.1786 (A)
	p value*	0.8535 (T)				0.3736 (T)
MDA (nmol/mL)	Day 0	0.68 (0.36)	(0.52, 0.83)	0.66 (0.39)			(0.51, 0.81)	0.9013 (T)
	Day 56	0.5 (0.37)	(0.34, 0.67)	0.38 (0.4)			(0.22, 0.53)	0.2545 (T)
	Change from baseline at day 56	−0.17 (0.64)	(−0.45, 0.10)	−0.29 (0.47)			(−0.47, −0.10)
	p value^#	0.3871 (A)
	p value*	0.2102 (T)		0.0036 (T)
LPS (EU/mL)	Day 0	72.61 (47.79)	(51.94, 93.27)	78.21 (55.45)			(56.71, 99.71)	0.7041 (T)
	Day 56	67.09 (87.45)	(29.27, 104.90)	74.75 (61.22)			(51.01, 98.49)	0.7150 (T)
	Change from baseline at day 56	−5.52 (70.99)	(−36.22, 25.18)	−3.46 (52.62)			(−23.87, 16.94)
	p value^#	0.9093 (A)
	p value*	0.7127 (T)			0.7303 (T)

Notes: ^$p-value was calculated using two sample t-test (T). *p-values were calculated using paired t-test (T). ^#p-values were calculated using ANCOVA with treatment as factor and baseline value, age and BMI as covariate vs placebo.

Abbreviations: CI, confidence interval; CRP, C-reactive protein; IL-6, interleukin-6; LPS, lipopolysaccharide; MDA, malondialdehyde; mITT, modified intention to treat; N, number of participants; SD, standard deviation.

Table 6 Summary of IWQOL-Lite-CT of the mITT Population

Parameters	Visit	LN-OS-22 (N=23)		Placebo (N=28)		p value^$
		Mean (SD)	95% CI	Mean (SD)	95% CI
Physical Impact	Day 0	10.22 (4.84)	(8.12, 12.31)	9.61 (4.57)	(7.84, 11.38)	0.6460 (T)
	Day 56	7.00 (4.72)	(4.96, 9.04)	7.64 (4.6)	(5.86, 9.43)	0.6259 (T)
	Change from baseline at day 56	−3.22 (4.91)	(−5.34, −1.10)	−1.96 (5.55)	(−4.12, 0.19)
	p value^#	0.4721 (A)
	p value*	0.0047 (T)		0.0718 (T)
Energy/Stamina	Day 0	2.43 (1.38)	(1.84, 3.03)	1.96 (1.23)	(1.49, 2.44)	0.2039 (T)
	Day 56	1.57 (1.38)	(0.97, 2.16)	1.89 (1.29)	(1.39, 2.39)	0.3847 (T)
	Change from baseline at day 56	−0.87 (1.18)	(−1.38, −0.36)	−0.07 (1.33)	(−0.59, 0.44)
	p value^#	0.0300 (A)
	p value*	0.0019 (T)		0.7787 (T)
Emotions	Day 0	12.26 (4.87)	(10.15, 14.37)	11.32 (5.16)	(9.32, 13.32)	0.5105 (T)
	Day 56	8.39 (4.39)	(6.49, 10.29)	9.46 (5.14)	(7.47, 11.46)	0.4323 (T)
	Change from baseline at day 56	−3.87 (4.26)	(−5.71, −2.03)	−1.86 (5.68)	(−4.06, 0.35)
	p value^#	0.1929 (A)
	p value*	0.0003 (T)		0.0951 (T)
Self-confidence/Self-esteem	Day 0	11.17 (6.1)	(8.53, 13.81)	10.32 (5.62)	(8.14, 12.50)	0.6065 (T)
	Day 56	8.83 (4.5)	(6.88, 10.77)	8.54 (5.41)	(6.44, 10.63)	0.8380 (T)
	Change from baseline at day 56	−2.35 (4.63)	(−4.35, −0.35)	−1.79 (5.51)	(−3.92, 0.35)
	p value^#	0.7382 (A)
	p value*	0.0236 (T)		0.0980 (T)
Sexual life	Day 0	1.65 (1.19)	(1.14, 2.17)	1.36 (1.16)	(0.91, 1.81)	0.3766 (T)
	Day 56	1.3 (0.88)	(0.93, 1.68)	1.39 (1.03)	(0.99, 1.79)	0.7456 (T)
	Change from baseline at day 56	−0.35 (1.3)	(−0.91, 0.21)	0.04 (1.4)	(−0.51, 0.58)
	p value^#	0.4867 (A)
	p value*	0.2130 (T)		0.8937 (T)
Social life	Day 0	1.48 (1.24)	(0.94, 2.01)	1.46 (1.17)	(1.01, 1.92)	0.9672 (T)
	Day 56	1.52 (1.08)	(1.05, 1.99)	1.39 (1.23)	(0.92, 1.87)	0.6957 (T)
	Change from baseline at day 56	0.04 (0.93)	(−0.36, 0.44)	−0.07 (1.27)	(−0.57, 0.42)
	p value^#	0.7373 (A)
	p value*	0.8243 (T)		0.7691 (T)
Productivity	Day 0	1.91 (1.44)	(1.29, 2.54)	1.89 (1.4)	(1.35, 2.43)	0.9599 (T)
	Day 56	1.52 (1.34)	(0.94, 2.10)	1.61 (1.4)	(1.07, 2.15)	0.8260 (T)
	Change from baseline at day 56	−0.39 (1.27)	(−0.94, 0.16)	−0.29 (1.36)	(−0.81, 0.24)
	p value^#	0.5402 (A)
	p value*	0.1536 (T)		0.2750 (T)
Total score	Day 0	41.13 (18.28)	(33.23, 49.03)	37.93 (18.24)	(30.86, 45.00)	0.5360 (T)
	Day 56	30.13 (16.08)	(23.18, 37.08)	31.93 (18.34)	(24.82, 39.04)	0.7144 (T)
	Change from baseline at day 56	−11 (12.8)	(−16.54, −5.46)	−6 (19.16)	(−13.43, 1.43)
	p value^#	0.3045 (A)
	p value*	0.0004 (T)		0.1091 (T)

Notes: ^$p-value was calculated using two sample t-test (T). *p-values were calculated using paired t-test (T). ^#p-values were calculated using ANCOVA with treatment as factor and baseline value, age and BMI as covariate vs placebo.

Abbreviations: CI, confidence interval; IWQOL-Lite-CT, Impact of Weight on Quality of Life-Lite-Clinical Trials Version; N, number of participants; mITT, modified intention to treat; SD, standard deviation.

Data Sharing Statement

The data used in the study is available on reasonable request from the corresponding author with due permission from the sponsor.