Accepted Manuscript

Title: Chromium supplementation and polycystic ovary

syndrome: A Systematic Review and Meta-Analysis

Authors: Siavash Fazelian, Mohamad H. Rouhani, Sahar Saraf

Bank, Reza Amani

PII: S0946-672X(17)30075-5
DOI: http://dx.doi.org/doi:10.1016/j.jtemb.2017.04.008
Reference: JTEMB 25920

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Received date: 10-2-2017

Revised date: 24-3-2017

Please cite this article as: Fazelian Siavash, Rouhani Mohamad H, Bank Sahar
Saraf, Amani Reza.Chromium supplementation and polycystic ovary syndrome: A
Systematic Review and Meta-Analysis.Journal of Trace Elements in Medicine and
Biology http://dx.doi.org/10.1016/j.jtemb.2017.04.008

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Chromium supplementation and polycystic ovary syndrome: A Systematic Review and Meta-Analysis.

Siavash Fazelian 1, Mohamad H Rouhani 1, Sahar Saraf Bank 1, Reza Amani 1*

1 Food Security Research Center, Department of Community Nutrition, School of

Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran;
*
Address for correspondence:

Reza Amani (PhD, R Nutr), Food Security Research center, Department of Clinical Nutrition, School of

Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.

E-mail: r_amani@mail.mui.ac.ir
ABSTRACT
Introduction: polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women. Some

vitamins and mineral can play role in improvement of PCOS. Chromium (Cr) is an essential element in

glucose and insulin homeostasis. However, findings are not consistent regarding PCOS improvement.

Therefore, the purpose of this paper was to assess the effect of Cr supplementation in PCOS that have not yet

fully been elucidated.

Methods: We searched ISI Web of Science, MEDLINE (1966 to June 2016), Google Scholar databases and

Proquest and identified eligible papers and extracted the following terms: total testosterone, DHEAS, insulin

sensitivity, fasting glucose , fasting insulin , OGTT 1 h glucose , OGTT 2 h glucose (mg/dL), LH (mIU/mL),

FSH, DHEAS , ferriman-Galwey score (FG score). We calculated overall effect size with random effects

model, between-study heterogeneity with I square (I2) statistic. Publication bias was assessed using Begg’s

test regression.

Result: Totally, 7 RCTs were selected. Results indicated that Cr supplementation had a beneficial effect on

BMI with effect size:-2.37 (kg/m2 ), 95% CI: -2.99, -1.76, p=0.001 and free testosterone concentration with

effect size= -0.52 (pg/mL), 95% CI: -0.83, -0.23, p=0.001. Cr reduced fasting insulin in subgroup of studies

with >10 participants with effect size: -0.86 mIU/ml, 95% CI: -0.67, -0.17; p=0.001. Cr supplementation had

no beneficial effects on reducing total testosterone, FG score, DHEA, FSH and LH.

Conclusion: This systematic review and meta-analysis shows that using Cr picolinate supplementation has

beneficial effects on decreasing BMI, fasting insulin and free testosterone in PCOS patients.

KEYWORDS: Meta-analysis, chromium , picolinate, polycystic ovary syndrome

Introduction

polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age

and is the main cause of infertility [1]. It is identified by reproductive dysfunction, hyperandrogenism,

anovulation, menstrual irregularly, infertility and pregnancy complications [2]. Obesity particularly
abdominal fat increases the risk of PCOS. Abdominal obesity has been observed in 50% of women with

PCOS [3]. Obesity and PCOS are two risk factors of type 2 diabetes (T2DM) [4]. PCOS patients have

higher prevalence of impaired glucose tolerance or T2DM [5].

Healthy diet and regular exercise can improve PCOS manifestations and insulin resistance. There is

specific information on nutritional factors contributed in managing PCOS. The effect of macronutrient

composition of diet on PCOS has been studied previously [6]. Available evidence has focused on the

influence of micronutrients intake on PCOS [7]. Recently, the role of trace elements including chromium,

copper, magnesium, zinc, manganese, calcium and selenium in the pathogenesis of PCOS has been

investigated [8].

Chromium (Cr) is a safe and highly tolerable trace element provided by dietary intake and dietary

supplementation, especially chromium picolinate [9, 10]. Cr is an essential element in glucose and insulin

homeostasis [11]. Previous study have reported that daily supplementation of Cr (200 to 1000 mcg) in

form of Cr picolinate has resulted in decreased blood glucose levels, however, conflicting results still exist

[10] and although several studies have examined the effect of Cr supplementation on PCOS, their findings

are not consistent. Some studies showed a positive impact of Cr supplementation on PCOS[9, 12-15]

while other evidence revealed that Cr had no favorable effects. Reported results in this field have not yet

been reviewed clearly. Therefore, the purpose of this paper was to assess the effectiveness of Cr

supplementation in women with PCOS.

Methods/design

We searched ISI Web of Science (isiwebofknowledge.com), MEDLINE (source: PubMed, 1966 to June

2016; http:// www.pubmed.com) , Google Scholar databases and Proquest to find relevant articles.

The following keywords were used to include studies published until Sep 2016: ("chromium"[tiab] OR

"chromium"[MeSH]) AND ("polycystic ovary"[tiab] OR "PCOS"[tiab] OR "insulin-sensitizing"[tiab] OR

"Polycystic ovary syndrome"[tiab] OR "Polycystic ovary syndrome"[MeSH] OR "polycystic ovarian

syndrome"[tiab] OR "Polycystic ovary disease"[tiab] OR "polycystic ovarian disease"[tiab] OR

"polycystic ovarian"[tiab] OR "Stein Leventhal Syndrome"[tiab] OR "Sclerocystic Ovarian

Degeneration"[tiab] OR "Ovarian Degeneration"[tiab] OR "Sclerocystic Ovary"[tiab] OR "PCO"[tiab] OR

"PCOD"[tiab] OR "ovary"[tiab] OR "ovarian"[tiab] OR "ovaries"[tiab] OR "ovarial"[tiab]). Clinical trials

which examined the effect of Cr supplementation in women with PCOS were chosen from the studies. We

had no language or time restriction. Two authors independently scanned titles and abstracts of the included

studies.

Data extraction and analysis

We identified eligible studies after screening the title, abstract, and finally, the full text. Two reviewers

extracted data separately and discussed regarding the discrepancies. The following data were extracted

from eligible articles: first author, publication year, participants' age, sample size, study design and

duration, dose and composition of supplements/placebo used in intervention/control group. Also,

mean±SD of the following outcome variables were extracted when available in the groups : total

testosterone, DHEAS (mcg/dL), insulin sensitivity (mU/L_1 · min_1) , fasting glucose (mg/dL), fasting

insulin (mU/L), OGTT 1 h glucose (mg/dL), OGTT 2 h glucose (mg/dL), LH (mIU/mL), FSH (mIU/mL),

DHEAS (ng/mL), ferriman-Galwey score (FG score).

SEs were converted to SDs. We also extracted mean±SD to calculate effect sizes. Data analysis was

performed using STATA 11.0 (Stata Corp., College Station, TX, USA). Statistically significant difference

was considered as P<0.05. We calculated overall effect size with random effects model. I square (I2)

statistic was used to test between-study heterogeneity. The sources of heterogeneity were detected by

performing subgroup analysis. Moreover, we used fixed effect model to assess between-subgroup

heterogeneity. Sensitivity analysis was carried out to examine changes in pooled effect size, when one

study had been removed. Begg’s test regression asymmetry test was used to indicate publication bias.

Results
We identified 187 articles in primary search of Google Scholar (https://scholar.google.com), Pubmed

(www.ncbi.nlm.nih.gov) and Proquest (www.proquest.com). Seven eligible clinical trials of dietary Cr

supplementation were selected by screening title, abstract and full text including total of 351 participants.

Four studies evaluated fasting blood glucose [9, 13, 14, 16], five studies tested free testosterone [9, 12, 15-

17], three articles evaluated total testosterone and BMI [9, 13, 17] and five studies examined fasting

insulin [9, 13, 15-17]. All patients were in reproductive age. Ferriman-Galwey score was evaluated in

three studies [12, 13, 15]. Levels of FSH and DHEA were tested in two publications [15, 17]. Three

studies had evaluated LH [9, 12, 15]. Design of five articles was parallel. Characteristics of seven eligible

clinical trials are summarized in Table 1. Four studies used Cr supplementation at a dosage of 200 mcg/d

while three studies prescribed 1000 mcg Cr per day. The duration of supplementation varied from 8 weeks

to 24 weeks.

Meta-analysis revealed that Cr supplementation had no effect on FBS level (effect size: -0.86 mg/dL, 95%

CI: -2.57, 0.86, p=0.33). We did not observe significant heterogeneity (I 2=0.0%, p=0.88).

Meta-analysis also revealed that Cr supplementation had a beneficial effect on fasting insulin (effect size: -

0.33 mIU/ml, 95% CI: -0.56, -0.10, p = 0.01). As heterogeneity was significant among studies (I 2=59.6%,

p=0.042%), we performed subgroup analyses according to the study sample size (sample size ≤10 and

>10). Cr supplementation reduced fasting insulin in subgroup of studies with >10 participants (effect size:

-0.86 mIU/ml, 95% CI: -0.67, -0.17; p=0.001) (I2=63.7%, P=0.06), However, overall effect in subgroup of

studies with ≤10 participants just showed a trend towards difference (figure 1 , effect size: -0.09 mIU/ml,

95% CI: -0.67, -0.17; p=0.065) (I2=12.5%, P=0.065).

Our analysis indicated that Cr supplementation had a beneficial effect on BMI (kg/m2 ) in PCOS women

(effect size:-2.37 (kg/m2 ), 95% CI: -2.99, -1.76, p=0.001) and heterogeneity was not significant among

studies (I2=0.0%, p=0.50,figure 2).

Random effect analysis revealed that Cr supplementation had a beneficial effect on free testosterone

concentrations in five selected papers (effect size= -0.52 (pg/mL), 95% CI: -0.83, -0.23, p=0.001) and

heterogeneity was not significant among studies (I 2=12.9%, p=0.33, figure 3).

Moreover, meta-analysis revealed that Cr supplementation had no beneficial effects on reducing total

testosterone (effect size:-4.57 (ng/dL) and CI: -11.91, 2.97, p=0.24) and heterogeneity was not significant

among studies (I2=26.5%, p=0.26).

Cr supplementation improved FG score in most patients, however, it showed no beneficial effects (effect

size:-0.87, CI: -2.09, 0.35, p=0.16) and heterogeneity was significant among three studies (I 2=85.2%,

p=0.001).

Our findings demonstrated that Cr supplementation had no beneficial effects on serum DHEA (effect size:

-13.71 (g/dL), CI: -34.32, 6.90, p=0.19) while heterogeneity was non-significant among studies (I2=0.0%,

p=0.51).

These results were the same for serum FSH (effect size:-4.57 (mIU/mL) , CI: -3.02, 2.35, p=0.8) and LH

(effect size: 0.83 (mIU/mL) , CI: -4.04, 5.69, p=0.74) as heterogeneity was significant among studies in

FSH (I2=84.3% , p=0.01) and LH (and I2 =76.7%, p=0.01).

We did not observe any evidence of publication bias regarding FBS (P = 0.73), BMI (P = 0.38), Free

testosterone (P = 0.99), FG score (P = 0.68), fasting insulin (P = 0.14), total testosterone (P = 0.60) and

LH (P = 0.60) using the Begg's test.

Discussion

In this meta-analysis, we observed that Cr picolinate supplementation significantly changed fasting

insulin, free testosterone and BMI in PCOS patient.

Obesity is a key factor that enhances the risk of PCOS and insulin resistance [18]. Insulin resistance and

high insulin serum levels cause hyperandrogenism by amplification of ovarian androgen secretion and

decreasing hepatic production of the androgen binding-protein [19, 20]. Improvement of PCOS symptoms
includes decreasing fasting blood sugar, androgen levels, acne, hirsutism, reducing the size of the follicles,

and regularity of menstruation [21].

Our analysis indicated that Cr supplementation could significantly reduce BMI. Weight loss increases

insulin sensitivity while decreases androgens levels [22]. Recently, in a systematic review, Pittler reported

that Cr picolinate increases lean body mass and basal metabolic rate and decreases percentage of body fat

[23]. A meta-analysis by Onakpoya et al. including 11 RCTs showed that Cr could significantly reduce

weight and body fat compared with placebo [24]. In a Meta-analysis, Pittler et al. reported that chromium

picolinate significantly lowered body weight in general population[25]. .

In our study, subgroup analysis indicated that Cr supplementation decreased fasting insulin in subgroup of

studies with >10 participants. Aclinical trial consisting of a large sample size using 200 μg Cr Picolinate

daily for 12 weeks reported significant effect on insulin resistance and FGIR (Fasting Glucose Insulin

Ratio) [12].

While results of a meta-analysis conducted by Yin and Phung reported no advantages of Cr picolinate on

HbA1C among diabetic patients [26], currently, there are sufficient evidence regarding the potential

effects of Cr supplementation on blood sugar levels [27] and increasing insulin sensitivity in type 2

diabetes[28]. We also ran subgroup analysis and observed that Cr supplementation could significantly

improve insulin sensitivity. However, further research should be performed with higher doses, longer

duration and with larger sample size to confirm the meaningful impact of Cr on insulin metabolism.

It has been shown that PCOS is more common in subjects with insulin resistance, type 2 diabetes mellitus

and metabolic syndrome [26]. Cr supplementation has significantly decreased blood triglycerides (TG)

and increased HDL-C levels [10]. Such reduction in TG would result in increased insulin sensitivity. Cr

also can link with chromodulin to boost receptor signaling [29]. Decreasing in serum insulin in this

intervention through the use of diazoxide to suppress insulin secretion is reported to significantly reduce

the androgens such as free testosterone [30].

 We tried to perform strong search strategy and to extract all the articles available from databases. A

limitation of our analysis was the limited number of related articles published with regard to women with

PCOS. Different doses of supplementation (200 to 1000 micrograms) in studies were another limitation of

our review. Selected articles had low sample size, however, this study can help researcher design stronger

method using various variables such as free testosterone, fasting insulin, FG score and symptoms of

disease in larger population.

In conclusion, this systematic review and meta-analysis indicates that using Cr picolinate supplementation

may exert beneficial effects on decreasing BMI, fasting insulin and free testosterone in women with PCOS.

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 Author (year) Effect Size (95% CI) Weight%

Sample size≤10
0.17 (-0.45, 0.79) 10.09
lucidi (2005)
Michael (2006) -0.25 (-0.70, 0.21) 15.12

Subtotal (I-squared = 12.5%, p = 0.285) -0.09 (-0.49, 0.30) 25.21

.

Sample size>10
-0.50 (-0.77, -0.24) 24.62
Ashus (2013)
-0.56 (-0.76, -0.37) 28.92
Amoee (2013)
Jamilian (2015) -0.12 (-0.44, 0.21) 21.25

Subtotal (I-squared = 63.7%, p = 0.063) -0.42 (-0.67, -0.17) 74.79

.

-0.33 (-0.56, -0.10) 100.00

Overall (I-squared = 59.6%, p = 0.042)

0
-.0.791 0.791

Figure 1. Forest plot of the effect of Cr supplementation on serum fasting insulin.

Author (year) Effect Size (95% CI) Weight%

Michael (2006) 1.39 (-4.91, 7.69) 0.96

Ashus (2013) -2.42 (-3.05, -1.79) 94.71

Amoee (2013) -2.21 (-5.17, 0.75) 4.33

Overall (I-squared = 0.0%, p = 0.496) -2.37 (-2.99, -1.76) 100.00

0
-7.69 7.69

Figure 2. Forest plot of the effect of Cr supplementation on BMI.

 Author (year)
Effect Size (95% CI) Weight%

lucidi (2005) 0.00 (-0.95, 0.95) 9.54

Michael (2006) 0.29 (-1.31, 1.89) 3.53

Amoee (2013) -2.00 (-3.96, -0.04) 2.38

Nermin (2015) -0.60 (-0.88, -0.32) 60.01

Jamilian (2015) -0.50 (-1.05, 0.05) 24.54

Overall (I-squared = 12.9%, p = 0.332) -0.52 (-0.83, -0.21) 100.00

-3.96 0 3.96

Figure 3. Forest plot of the effect of Cr supplementation on serum free testosterone.

 Flow diagram

figure. 1. Selection of studies for the systematic review and meta-analysis

Identification

Records identified through database searching and

Records after duplicates removed
(n=187)

Records excluded (n=174)

Animal study(1)
Not relevant (166)
Screening

Cross sectional studies (n=7)

Records screened
(n=187)

Full-text articles assessed Full-text articles excluded

for eligibility
Eligibility

(n=6), Case-control studies

(n=13) (n=6)

Studies included in
qualitative synthesis
(n=7)
Included

Studies included in
quantitative synthesis
(meta-analysis)
(n=7)
Table 1. Characteristics of the included studies

Author (year) Subjects Age range Intervention Control Duration

(sample (y) Study (composition and (composition (wks) Outcome
size) design sample size ) and sample
size)
Lucidi 10 patients 18- 39 y parallel 200 mcg/day Cr Placebo 16 OGTT 1 hour glucose (mg/dL) and OGTT 2
et al. with PCOS picolinate (n=4 patients) wk hours glucose (mg/dL) significantly decreased.
(2005) (n=6 patients)
Lydic 5 patients 19–42 y pre-post 1,000 mcg/day Cr ……………. 8 Glucose disposal rate (mg/kg/min) significantly
et al. with PCOS picolinate wk reduced but other variables had not significant
(2006) (5 patients) difference
Amr 35 patients ≤18 y pre-post 1000 mcg/day Cr …………… 24 Significant reduction in mean ovarian volume ,
et al. with PCOS picolinate wk total follicular count and free testosterone was
(2015) (n=35 patients) observed
Mehri Jamilian 60 patients 18–40 y double- 200 mcg/day Cr Placebo 8 Adjusted changes showed that Chromium
et al. with PCOS blind picolinate (cellulose) wk supplementation had beneficial effects on acne,
(2015) RCT (n = 30) (n = 30) hirsutism (evaluated with mF-G scores), high
sensitivity C-reactive protein (hs-CRP), total
antioxidant capacity (TAC), and
malondialdehyde MDA levels compared with
the placebo.

Jamilian 64 patients 18-40 y RCT 200 mcg/day Cr Placebo 8 Adjusted changes showed significant reduction
et al. with PCOS picolinate (cellulose) wk in serum insulin levels, HOMA-IR, HOMA-
(2015) (n = 32) (n = 32) Band, triglycerides, VLDL-cholesterol, and
cholesterol concentrations. QUICKI score
significantly increased compared with the
placebo.
Ashoush 85 patients 20–35 y double- 1000 mcg/day Cr placebo 24 BMI and fasting serum insulin had significant
et al. with PCOS blind, picolinate (n=44) (n=41) wk reduction and fasting glucose insulin ratio
(2015) RCT (FGIR), chances of ovulation and regular
menstruation after supplementation increased.
Amooee 92 patients Non double- 200 mcg/day Cr 1500 mg/day 12 Fasting blood sugar (FBS) and serum fasting
et al. with PCOS menopause blind picolinate Metformin wk insulin had significantly reduction after
(2013) RCT (n=46) (n=46) chromium supplementation. Testosterone and
free testosterone in patients who received.
Metformin significantly decreased.