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The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.
The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Intervention | Experimental | Iodine tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine tablet | Dietary Supplement | Iodine tablets containing 200 ug iodine as potassium iodate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TSH (thyroid-stimulating hormone) | change from baseline to 6 months | |
| change in fasting insulin | change from baseline to 6 months | |
| change in the LDL cholesterol/ HDL cholesterol ratio | change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| fasting glucose | baseline, 3 months and 6 months | |
| plasma leptin | baseline, 3 months and 6 months | |
| LDL cholesterol |
| Measure | Description | Time Frame |
|---|---|---|
| T3 | baseline, 3 months and 6 months | |
| T4 | baseline, 3 months and 6 months | |
| total cholesterol |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Aeberli, PhD | ETH Zurich (Switzerland) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite Caddi Ayad, Faculte de Medecine et de Pharmacie | Marrakesh | Morocco | ||||
| University Cadi Ayyad, Faculte des Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26203098 | Derived | Herter-Aeberli I, Cherkaoui M, El Ansari N, Rohner R, Stinca S, Chabaa L, von Eckardstein A, Aboussad A, Zimmermann MB. Iodine Supplementation Decreases Hypercholesterolemia in Iodine-Deficient, Overweight Women: A Randomized Controlled Trial. J Nutr. 2015 Sep;145(9):2067-75. doi: 10.3945/jn.115.213439. Epub 2015 Jul 22. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007455 | Iodine |
| ID | Term |
|---|---|
| D006219 | Halogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Placebo tablet | Dietary Supplement | Placebo tablet without iodine |
|
| baseline, 3 months and 6 months |
| HDL cholesterol | baseline, 3 months and 6 months |
| Urinary iodine | change from baseline to 6 months |
| baseline, 3 months and 6 months |
| TSH | 3 months |
| leptin | 3 months |
| Marrakesh |
| Morocco |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |