Clinical trial · Interventional
Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of our study is to determine the effects of fish protein on insulin sensitivity in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity, glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian function.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Sensitivity | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Semi-controlled intervention with other animal proteins | Other | — | UNRESOLVED |
| Semi-controlled nutritional intervention with fish protein diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Semi-controlled intervention with fish protein diet
- description
- Women with polycystic ovarian syndrome who are assigned to a 12 weeks experimental diet containing cod as the protein source.
- interventionNames
- Other: Semi-controlled nutritional intervention with fish protein diet
- type
- ACTIVE_COMPARATOR
- label
- Semi-controlled intervention with other animal proteins
- description
- Women with polycystic ovarian syndrome who are assigned to a 12 week experimental diet containing beef, pork, veal, eggs and milk products (BPVEM) as protein sources.
- interventionNames
- Other: Semi-controlled intervention with other animal proteins
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * women * 18 to 45 years old * having polycystic ovarian syndrome * overweight (BMI\>27) * insulin resistance based on fasting insulin levels in the upper 95th percentile (\>90pmol/L) * non-diabetic Exclusion Criteria: * diabetes * hysterectomy * abnormal endometrial biopsy if abnormal bleeding in the last 6 months * clinical evidence of Cushing's syndrome * congenital adrenal hyperplasia (17-OH progesterone\>10nmol/l) * excessive androgens suspicious of a tumour * prolactins levels \>50μg/l * previous breast, uterus, ovary or liver neoplasia * use of medication known to affect glucose and lipid metabolisms (e.g. steroid hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin) * depo-medroxyprogesterone acetate injection in the last year * important weight loss or weight gain within the last 6 months * chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease or major surgery within the last 3 months * dietary incompatibility with calcium supplementation and/or fish consumption (allergy, intolerance, dislike)
References
Publications (0)
Data not yet available