Zinc 3,5,5-trimethylhexanoate

Direct observations: clinical cases, poisoning incidents and other

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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

The Effects of Zinc Supplements on Lipoproteins and Copper Status

Author:

Samman S & Roberts DCK

Year:

1988

Bibliographic source:

Atheroscl. 70:247-252

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

repeated dose toxicity: oral

Principles of method if other than guideline:

A double-blind cross-over trial was conducted on healthy human volunteers for 12 wks to evaluate the effect of the test material on plasma lipoproteins.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

Details on test material:

- Name of test material (as cited in study report): Zinc sulfate
- Other: Obtained from Zincaps, Protea Pharmaceuticals

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 47
- Sex: 26 female and 21 male
- Age: 27 yr (female) and 28 yr (male)
- Demographic information: Females weighing less than males
- 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:

Double-blind cross-over trial, 50 mg Zn (as ZnSO4) or placebo (lactose) was administered to healthy volunteers three times a day for six weeks. Volunteers were allocated randomly to Zn treatment for six weeks followed by placebo regimen for six weeks, or vice versa.

Examinations:

- Estimation of plasma lipoproteins: Total cholesterol, HDL & LDL-cholesterol
- Estimation of plasma Zn levels
- Estimation of Cu status by haematocrit measurements and estimation of ferroxidase activity of serum caeruloplasmin and antioxidant activity of Erythrocyte superoxide dismutase (E-SOD) & CuZn E-SOD

Medical treatment:

No

Results and discussion

Clinical signs:

Gastrointestinal symptoms

Results of examinations:

Plasma lipoproteins:
- Total cholesterol: Remains unchanged in male/female
- LDL-cholesterol: In females, decreased from 2.38 to 2.17 mmol/L; no effect in males
- Ferroxidase activity of serum caeruloplasmin: In females, reduced from 13.0 to 11.3 U/mL; no effect in males
- Antioxidant activity of E-SOD: In females, reduced from 4,557 to 3,638 U/g Hb; no effect in males
- Antioxidant activity of E-SOD: In females, reduced from 2,184 to 1,672 U/g Hb; no effect in males
- Plasma Cu and haematocrit: Remains unchanged in male/female

Effectivity of medical treatment:

Not applicable

Outcome of incidence:

Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test material reduced LDL-cholesterol, ferroxidase activity of serum caeruloplasmin and antioxidant activity of E-SOD & CuZn E-SOD in females whereas no effect observed in males.

Executive summary:

A double-blind cross-over trial was conducted on 47 (26 female & 21 male) healthy human volunteers for 12 wks to evaluate the effect of the test material (50 mg Zn as ZnSO4 or placebo, three times a day, for six weeks) on plasma lipoproteins.

 

Under the test conditions, the test material reduced mean LDL-cholesterol level, ferroxidase activity of serum caeruloplasmin and antioxidant activity of E-SOD & CuZn E-SOD in females whereas no effect observed in males.