NCT05830487

Brief Summary

Recently, the negative effects of advanced glycation end products on the pathophysiology of some diseases have attracted attention. This study was planned to evaluate the effect of dietary intervention and weight loss on serum advanced glycation and disease pathogenesis in patients with polycystic ovary syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

January 25, 2023

Last Update Submit

April 24, 2023

Conditions

Polycystic Ovary SyndromeDiet Habit

Keywords

advanced glycation end productsdiet

Outcome Measures

Primary Outcomes (5)

  • Serum advanced glycation end products levels

    The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention

    12 weeks

  • Total antioxidant/oxidant capacity

    The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention

    12 weeks

  • İnflammation

    The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention

    12 weeks

  • Cardio metabolic profile

    The comparison of fasting insulin (mg/dL), fasting blood sugar (mg/dL), lipid parameters (triglyceride (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), total cholesterol (mg/dL)) values of 24 patients at baseline and week 12.

    12 weeks

  • Hormonal Profile

    From hormonal indicators total testosterone (ng/mL), sex hormone-binding globulin ng/mL) , Anti mullerian hormone (ng/mL) values of 24 patients at baseline and week 12 will be compared.

    12 weeks

Secondary Outcomes (4)

  • Body composition

    12 weeks

  • Body weight

    12 weeks

  • Body Mass İndex

    12 weeks

  • Circumference measurements

    12 weeks

Study Arms (2)

Low AGE diet with reduced energy and fat

EXPERIMENTAL

Low advanced glycation end products diet with reduced energy and fat

Behavioral: Low AGE diet with reduced energy and fat

Energy and fat-reduced normal diet

EXPERIMENTAL

only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with.

Behavioral: Energy and fat-reduced normal diet

Interventions

Low AGE diet with reduced energy and fatBEHAVIORAL

This group will be given a low AGE diet with reduced energy and fat,.

Low AGE diet with reduced energy and fat
Energy and fat-reduced normal dietBEHAVIORAL

This group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with

Energy and fat-reduced normal diet

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Presence of chronic disease (Diabetes, Hypertension, Atherosclerotic heart diseases, gastrointestinal system diseases..)
  • Being in pregnancy-lactation or menopause period
  • Using oral contraceptive medication
  • Using vitamin-mineral support
  • Receiving a special dietary treatment
  • To have applied a weight loss diet in the last 3 months
  • To smoke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hacettepe University

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozdemir M, Mumusoglu S, Bilgic P. Comparison of Metabolic and Hormonal Profiles between Low-Advanced Glycation End Products (AGEs) and Standard AGEs-Containing Weight-Loss Diets in Overweight Phenotype-A PCOS Patients: A Randomized Clinical Trial. Reprod Sci. 2025 Apr;32(4):1190-1201. doi: 10.1007/s43032-025-01808-8. Epub 2025 Feb 14.

    PMID: 39953370DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeFeeding Behavior

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • merve özdemir

    researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 25, 2023

First Posted

April 26, 2023

Study Start

November 30, 2021

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)