The influence of fat intake, estrogen, age, and gender on postprandial lipds and glucose

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002326-39-DK

Enrollment

Registered

2015-05-22

Start date

2015-08-19

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers MedDRA version: 18.0 Level: LLT Classification code 10050903 Term: Postmenopausal symptoms System Organ Class: 100000004872

Interventions

Trade Name: Estradiol Product Name: Estradiol Product Code: 111530 Pharmaceutical Form: Tablet INN or Proposed INN: ESTRADIOL HEMIHYDRATE Other descriptive name: estradiol Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy individuals age 45-55 and 65-80 years of both gender. Only the women age 45-55 are subjected to the estrogen replacement and the intake is randomized to start with either placebo or active substance for these women only. All other groups, i.e. males age 45-55, and both gender age 65-80 act as controls Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Person suffering form dumping syndorme, hypercholesterolemia, hypertension, abuse of substance or alcohol, known kidney-, liver-, biliary-, cardiovascular and metabolic diseases, thromboembolic disorders, active cancer of the uterus or breast and other hormone therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Describing postprandial effects of hormonal replacement therapy with estrogen-like substances. Lipids and glucose are measured after a standard test meal after 3 months of ingestion of either active substance or placebo;Secondary Objective: Different types of hormone replacement are evaluated for their effect on postprandial lips oga glucose metabolism. Similarly age and gender effects are compared;Primary end point(s): postprandial area under the curve for cholesterols (total, HDL, LDL),triglycerides, and free fatty acids;Timepoint(s) of evaluation of this end point: after 2 years the blood samples will be measured in one batch	—

Measure

Time frame

Main Objective: Describing postprandial effects of hormonal replacement therapy with estrogen-like substances. Lipids and glucose are measured after a standard test meal after 3 months of ingestion of either active substance or placebo;Secondary Objective: Different types of hormone replacement are evaluated for their effect on postprandial lips oga glucose metabolism. Similarly age and gender effects are compared;Primary end point(s): postprandial area under the curve for cholesterols (total, HDL, LDL),triglycerides, and free fatty acids;Timepoint(s) of evaluation of this end point: after 2 years the blood samples will be measured in one batch

—

Secondary

Measure	Time frame
Secondary end point(s): postprandial area under the curve for glucose and insulin;Timepoint(s) of evaluation of this end point: after 2 years the blood samples will be measured in one batch	—

Countries

Denmark

Contacts

Public ContactGynecology Department,Herning Hospi

Gynecology Department,Herning Hospital

finlau@rm.dk4578434614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026