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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Zinc Lowers High-Density Lipoprotein-Cholesterol Levels
Author:
Hooper PL, Visconti L, Garry PJ & Johnson GE
Year:
1980
Bibliographic source:
JAMA. 244(17): 1960-1961

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
repeated dose toxicity: oral
Principles of method if other than guideline:
A clinical trial was conducted on healthy human volunteers for five weeks to evaluate the effect of the test material on plasma lipoproteins.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zinc sulfate

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 20 (treatment group: 12, control: 8)
- Sex: Male
- Age: 23-35 yr
- Other: Subjects were asked not to change their lifestyle pattern and particularly habits known to alter lipid metabolism (ingestion of alcohol, diet, exercise and smoking)
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Clinical trial: 80 mg Zn (as 220 mg ZnSO4) or placebo was administered to healthy volunteers twice a day for five weeks.
Examinations:
- Estimation of plasma lipoproteins: Total cholesterol, triglyceride, HDL & LDL-cholesterol was estimated on a weekly basis (from week 1 to 7 and at week 16)
Medical treatment:
No

Results and discussion

Clinical signs:
No data
Results of examinations:
Plasma lipoproteins:
- HDL-cholesterol: Decreased (25 %) from 40.5 to 30.1 mg/dL
- Total cholesterol, triglyceride & LDL-cholesterol: Unchanged

For details please see 'Table 1' of reference
Effectivity of medical treatment:
Not applicable
Outcome of incidence:
Not applicable

Any other information on results incl. tables

Table 1: Serum Lipid, Lipoprotein, and Plasma Zinc Levels in Subjects Receiving Zinc*

 

Baseline

5th week

7th week

16th week

Total cholesterol, mg/dL

164.8 ± 18.1

161.8 ± 19.2

163.7 ± 17.0

171.7 ± 21.1

Triglyceride, mg/dL

111.1 ± 40.1

117.9 ± 35.6

123.2 ± 39.7

115.0 ± 41.0

Low-density lipoprotein, mg/dL

102.1 ± 16.1

104.2 ± 17.7

10.9.0 ± 16.4

110.2 ± 17.0

High-density lipoprotein, mg/dL

40.5 ± 6.5

33.5 ± 5.0

30.1 ± 5.4

38.4 ± 6.3

Zinc, µg/dL

94.8 ± 16.9

145.7 ± 69.08

--

89.7 ± 12.2

*Mean ± SD for 12 determinations

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the test material reduced plasma HDL-cholesterol levels whereas total cholesterol, triglyceride & LDL-cholesterol remain unchanged.
Executive summary:

A clinical trial was conducted on 20 healthy male human volunteers for five wks to evaluate the effect of the test material (80 mg Zn as ZnSO4 or placebo, twice a day) on plasma lipoproteins.

 

Under the test conditions, the test material reduced plasma HDL-cholesterol levels whereas total cholesterol, triglyceride & LDL-cholesterol remain unchanged.