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A comparison of the portfolio low-carbohydrate diet and the ketogenic diet in overweight and obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial.

Trials
August 9, 2023
Maryam Sharifi Najafabadi et al. (4 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether a portfolio low-carbohydrate diet (PLCD) or a ketogenic diet (KD) is more effective in alleviating PCOS symptoms in overweight or obese women.

Results Summary

The abstract does not provide results, as the study appears to be ongoing or not yet concluded.

Population

Overweight or obese women diagnosed with polycystic ovary syndrome (PCOS).

Effective Dosage

PLCD (40% carbohydrates) and KD (10% carbohydrates).

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
portfolio low-carbohydrate diet (PLCD)
decrease
PCOS symptoms
overweight or obese women diagnosed with PCOS
-
more effective in alleviating
#1
ketogenic diet (KD)
decrease
PCOS symptoms
overweight or obese women diagnosed with PCOS
-
more effective in alleviating
#2
PLCD or KD
decrease
PCOS manifestations
PCOS women
-
more advantageous effects on attenuating
#3
Abstract

BACKGROUND: Polycystic ovary syndrome (PCOS) is one of the most frequent endocrine disorders among women of fertile age. Women with PCOS manifest clinical symptoms like menstrual dysfunction, hirsutism, insulin resistance, and hyperinsulinemia. As excessive amounts of insulin levels directly increase ovarian production of androgens, hyperinsulinemia and insulin resistance are considered as the pathogenesis factors of PCOS. The portfolio low-carbohydrate diet (PLCD) is a plant-based diet with 40% carbohydrates combined with five cholesterol-lowering foods and nutrients. On the other hand, the ketogenic diet (KD) is a nutritional protocol with 10% carbohydrates. The purpose of this study is to determine whether PLCD or KD is more effective in alleviating PCOS symptoms. METHODS: Forty-six overweight or obese women diagnosed with PCOS will be randomly stratified to receive either PLCD or KD for 8 weeks. Measures related to anthropometric and body composition, glucose, and insulin level, HOMA-IR, sex hormones, lipid profile, quality of life, dietary intake, physical activity, and Ferriman-Gallwey score of all participants will be accessed before and after the intervention. DISCUSSION: Since the first line treatment of PCOS is lifestyle adjustment including diet control and exercise, there has not been determined the optimal diet for this population of women yet. Hence, the goal of conducting this study is to determine whether the PLCD or the KD could have more advantageous effects on attenuating PCOS manifestations. The result of this investigation will give us new insight into curing this disease and will provide evidence-based recommendations for prescribing an optimal diet for PCOS women. TRIAL REGISTRATION: IRCT20200912048693N3, Trial registered 2022-12-14. https://www.irct.ir/trial/67548.

Medical Subject Headings (MeSH)
FemaleHumansDiet, Carbohydrate-RestrictedDiet, KetogenicInsulin ResistanceObesityOverweightPolycystic Ovary SyndromeQuality of LifeRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations2
Citations/Year1.0
Relative Citation Ratio0.65
NIH Percentile35%
Research Impact Scores
APT Score0.50
Weight Score2.62
Normalized Score0.57
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