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Effects of three medical nutrition therapies on nutritional metabolism and intestinal flora in overweight/obese with polycystic ovary syndrome (PCOS): Study protocol for a randomised controlled trial.

Asia Pacific journal of clinical nutrition
January 1, 2023
Pan Dou et al. (8 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of a high-protein diet (HPD), a high-protein and high-dietary fiber diet (HPHFD), and a calorie-restricted diet (CRD) on metabolic health and gut microbiota in overweight/obese PCOS patients.

Results Summary

The study compared body weight, body fat percentage, lean body mass, blood lipids, inflammation, glucose tolerance, blood pressure, and gut microbiota compositions across the three diet groups, but specific results for the high-protein diet were not detailed in the abstract.

Population

Overweight/obese patients with polycystic ovary syndrome (PCOS).

Effective Dosage

1.5-2.0 g/kg protein per day for the HPD group.

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
energy restriction
decrease
bodyweight
patients with polycystic ovary syndrome (PCOS)
-
could be beneficial for controlling
#1
high-protein diet (HPD)
neutral
metabolic health
overweight/obese PCOS patients
-
effects
#2
high-protein diet (HPD)
neutral
gut microbiota
overweight/obese PCOS patients
-
effects
#3
high-protein and high-dietary fiber diet (HPHFD)
neutral
metabolic health
overweight/obese PCOS patients
-
effects
#4
high-protein and high-dietary fiber diet (HPHFD)
neutral
gut microbiota
overweight/obese PCOS patients
-
effects
#5
calorie-restricted diet (CRD)
neutral
metabolic health
overweight/obese PCOS patients
-
effects
#6
calorie-restricted diet (CRD)
neutral
gut microbiota
overweight/obese PCOS patients
-
effects
#7
Abstract

BACKGROUND AND OBJECTIVES: Observational studies have shown that energy restriction could be beneficial for controlling bodyweight in patients with polycystic ovary syndrome (PCOS). We aim to compare the effects of a high-protein diet (HPD), a high-protein and high-dietary fiber diet (HPHFD), and a calorie-restricted diet (CRD) on metabolic health and gut microbiota in overweight/obese PCOS patients. METHODS AND STUDY DESIGN: We will enroll a total of 90 overweight/obese PCOS patients into this eight-week open-label randomised controlled trial. Participants will be randomly assigned to three groups: CRD group (energy coefficient 20 kcal/kg.day, water ≥1500 mL, 0.8-1.2 g/kg protein, carbohydrate energize 55-60%, and fat energize 25-30%), HDP group (energy coefficient 20 kcal/kg.day, water ≥1500 mL, and 1.5-2.0 g/kg protein) and HPHFD group (based on the high protein diet with 15 g more dietary fiber supplement). The primary outcome is body weight, body fat percentage, and lean body mass. The secondary outcomes will include changes in blood lipids, inflammation, glucose tolerance, blood pressure, and gut microbiota compositions. Between-group differences in adiposity measurements at baseline will be compared using one-way analysis of variance (ANOVA) or Kruskal-Wallis test when appropriate. Within-group difference after 8-week intervention will be compared using paired t-test or Wilcoxon signed rank test. Between-group differences in adiposity measurements after 8-week diet intervention will be compared using linear mixed model and ANCOVA. The gut microbiota will be analyzed using 16S amplicon sequencing and the sequencing data will be analyzed using the standardized QIIME2 piperline.

Medical Subject Headings (MeSH)
FemaleHumansOverweightGastrointestinal MicrobiomePolycystic Ovary SyndromeWeight LossInsulin ResistanceObesityBody WeightDietary FiberRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
0
Research Impact Scores
APT Score0.05
Weight Score2.36
Normalized Score0.67
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