Dataset Information

Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study.

ABSTRACT:

Objective

To study the impact of a very-low-carbohydrate (VLC) diet for 16 weeks in overweight or obese women with polycystic ovary syndrome (PCOS).

Design

Single-arm prospective pilot study.

Setting

We recruited participants using medical records from an academic medical center.

Patients

Twenty-nine overweight or obese women (body mass index, 25-50 kg/m²) with PCOS.

Interventions

We taught participants to follow a VLC diet and provided information about a variety of behavioral skills including mindfulness and positive affect using an online 16-week intervention.

Main outcome measures

Changes in body weight, glycated hemoglobin, and PCOS-related quality of life.

Results

The intervention led to positive health outcomes including decreases in percent weight (mean difference = -7.67, SD = 6.10) and glycated hemoglobin level (mean difference = -0.21%, SD = 0.27), an increase in sex hormone binding globulin level (mean difference = 9.24 nmol/L, SD = 16.34), and increases in PCOS-related quality of life measures, including menstrual predictability (mean difference = 2.10, SD = 2.76) and body hair (mean difference = 1.14, SD = 1.04). The low-density lipoprotein cholesterol level increased (mean difference = 0.23 mmol/L, SD = 0.49).

Conclusions

The results suggest that a VLC dietary intervention has potential to promote both weight loss and glycemic control in overweight and obese adults with PCOS, two key components in the prevention of type 2 diabetes.

Trial registration number

NCT03987854.

SUBMITTER: Missel AL

PROVIDER: S-EPMC8655401 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study.

Missel Amanda L AL O'Brien Alison Virginia AV Maser Haley H Kanwal Amreen A Bayandorian Hovig H Martin Symone S Carrigan Paige P McNamee Rebecca R Daubenmier Jennifer J Isaman Deanna J M DJM Padmanabhan Vasantha V Smith Yolanda R YR Aikens James E JE Saslow Laura R LR

F&S reports 20210904 4

<h4>Objective</h4>To study the impact of a very-low-carbohydrate (VLC) diet for 16 weeks in overweight or obese women with polycystic ovary syndrome (PCOS).<h4>Design</h4>Single-arm prospective pilot study.<h4>Setting</h4>We recruited participants using medical records from an academic medical center.<h4>Patients</h4>Twenty-nine overweight or obese women (body mass index, 25-50 kg/m<sup>2</sup>) with PCOS.<h4>Interventions</h4>We taught participants to follow a VLC diet and provided information ...[more]

PMID: 34934978

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Project description:IntroductionAll Veterans Affairs (VA) Medical Centers offer the MOVE! Weight Management Program to help patients achieve and maintain a healthy weight through a calorie-restricted, low-fat diet and increased physical activity. Yet, most MOVE! participants do not achieve clinically significant weight loss of ≥5%. A carbohydrate-restricted diet may help more Veterans to achieve ≥5% weight loss.MethodsThis was a single-arm explanatory sequential mixed methods pilot study conducted in one VA health care system. Veterans with prediabetes and body mass index ≥25 kg/m2 were invited to participate in a group-based, virtual, very low-carbohydrate Diabetes Prevention Program (VLC-DPP) consisting of 23 sessions over 12 months. Participants were taught to follow a very low-carbohydrate eating pattern, defined as 20-35 grams of net carbohydrates per day. The primary outcomes were measures of feasibility and acceptability, including program uptake and session attendance. Secondary outcomes included change in weight, hemoglobin A1c, lipids, and patient-reported measures of food cravings, stress eating, perceived health status, and motivation. Interviews were conducted at 6 months to identify factors that facilitated or hindered participants' achievement of ≥5% weight loss.ResultsAmong 108 screened Veterans, 21 enrolled in the study (19%), and 18 were included in the analytic cohort. On average, participants attended 12.4/16 weekly sessions and 3.6/8 bimonthly or monthly sessions. At 12 months, mean percent weight loss was 9.4% (SD = 10.7) with 9 participants (50%) achieving ≥5% weight loss. Three factors facilitated achievement of ≥5% weight loss among 10/16 interviewees: (1) enjoyment of low-carbohydrate foods; (2) careful monitoring of carbohydrate intake; and (3) reduced hunger and food cravings. Three factors hindered achievement of ≥5% weight loss among 6/16 interviewees: (1) food cravings, particularly for sweets; (2) challenges with maintaining a food log; and (3) difficulty with meal planning.ConclusionA VLC-DPP is feasible and acceptable and shows preliminary efficacy among Veterans with prediabetes. The program's weight loss effectiveness compared to standard MOVE! should be evaluated in a larger-scale trial. Such a program may be offered in addition to the standard MOVE! program to expand the menu of evidence-based lifestyle counseling options for Veterans.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04881890, identifier NCT04881890.

Project description:ObjectivesTo determine the therapeutic effect of a Mediterranean diet (MED) combined with a low-carbohydrate (LC) dietary model in overweight polycystic ovary syndrome (PCOS) patients.MethodsIn this 12-week randomized controlled clinical trial, 72 overweight patients with PCOS were randomly assigned to one of two energy-restricted dietary models: the MED/LC diet or the Low fat (LF) diet. After the intervention, the number of the two groups returned to normal menstruation was counted. Body weight, body mass index (BMI), waist circumference, waist-hip ratio (WHR), body fat percentage (BF%), serum fasting insulin(FINS), fasting plasma glucose(FPG), insulin resistance index (HOMA-IR), quantitative insulin sensitivity index (QUIKI), total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglyceride (TG), total testosterone (TT), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin (PRL) were compared between 2 groups before and after intervention.ResultsMED/LC group had more significant reduction trend in weight (-6.10 ± 1.52 kg vs -4.79 ± 0.97 kg, P < 0.05), BMI (-2.12 ± 0.57 kg/m2 vs -1.78 ± 0.36 kg/m2, P < 0.05), WC (-6.12 ± 5.95 cm vs -3.90 ± 1.58 cm, P < 0.05), WHR (-0.06 ± 0.02 vs -0.03 ± 0.02, P < 0.05), BF% (-2.97% ± 1.78% vs -1.19% ± 0.91%, P < 0.05), TT (-0.20 ± 0.24 ng/mL vs 0.08 ± 0.11 ng/Ml, P < 0.001), LH (-5.28 ± 3.31 mIU/mL vs -3.39 ± 3.64 mIU/mL, P < 0.05), and LH/FSH (-1.18 ± 0.75 vs -0.66 ± 1.05, P < 0.05) compared with the LF group. In addition, FPG (0.05 ± 0.38 mmol/mL vs -0.50 ± 1.01 mmol/mL, P < 0.001), FINS (-4.88 ± 6.11 μU/mL vs -8.53 ± 5.61 μU/mL, P < 0.01), HOMA-IR index (-1.11 ± 1.51 vs -2.23 ± 0.25, P < 0.05), and QUIKI index (0.014 ± 0.016 vs 0.028 ± 0.019, P < 0.05) decreased significantly in the MED/LC group compared with the LF group. Comparing the changes in lipid parameters between the two groups (LF vs MED/LC), significant differences in TG (-0.33 ± 0.32 mmol vs -0.76 ± 0.97 mmol, P < 0.05), TC (-0.40 ± 1.00 mmol vs -1.45 ± 2.00 mmol, P < 0.05), and LDL-C (-0.41 ± 1.05 mmol vs -0.73 ± 0.76 mmol, P < 0.05) were observed.ConclusionThe results of this study suggest that the MED/LC diet model is a good treatment for overweight PCOS patients, significantly restoring their menstrual cycle, improving their anthropometric parameters and correcting their disturbed endocrine levels, and its overall effectiveness is significantly better than the LF diet model. Therefore, this study recommends that the MED/LC diet model can be used in the clinical treatment of patients with overweight PCOS.

Project description:Several studies have reported the association between polycystic ovary syndrome (PCOS) and low-grade chronic inflammation to be of uncertain cause: obesity, insulin resistance, or PCOS itself. The aim of the study was to investigate the WBC (white blood cell) count and CRP (C-reactive protein) concentration in women with PCOS and to determine the factors that affect their concentration. The study included 200 women aged 18-40 with PCOS and 105 healthy women as the control group, recruited in the Department of Gynaecological Endocrinology of Medical University in Warsaw from 2016 to 2018. Each patient underwent clinical, biochemical, and ultrasonographic assessments. WBC and CRP were significantly higher in the PCOS group (Z = -2,353, p = 0,019 and Z = -2,453, p = 0,014). WBC positively correlated with serum insulin at 0, 60, and 120?min during the oral glucose tolerance test (INS0: r = 0,221, p = 0,001; INS1: r = 0,194, p = 0,003; INS2: r = 0,022, p = 0,001), testosterone (r = 0,130, p = 0,046), androstenedione (r = 0,212, p = 0,001), and DHEAS (r = 0,178, p = 0,006) and negatively correlated with progesterone (r = -0,204, p = 0,002), estradiol (r = -0,140, p = 0,032), and SHBG (r = -0,308, p < 0,001). CRP positively correlated with insulin concentration in 0, 60, and 120?min during the oral glucose tolerance test (INS0: r = 0,343, p < 0,001; INS1: r = 0,276, p = 0,001; INS2: r = 0,320, p < 001) and negatively correlated with progesterone (r = -0,194, p = 0,030) and SHBG (-0,244, p = 0,005). We also estimated positive correlation between BMI and serum CRP and WBC concentration. Multiple linear regression analysis showed that CRP values are positively associated with BMI (beta = 0,374, p < 0,001) and insulin level (INS1) (beta = 0,282, p = 0,004); and WBC results are negatively associated with SHGB (beta = -0,284, p < 0,001) but positively associated with testosterone (beta = 0,163, p = 0,024) and BMI (beta = 0,157, p = 0,047). PCOS is associated with increased WBC and CRP concentrations. The main predicting factors of increased CRP are BMI and insulin resistance, but there is also a relationship between WBC count in PCOS and androgen concentration itself so that inflammation may be mediated not only through adiposity but also through increased androgen concentration.

Project description:BackgroundPolycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.ObjectivesTo assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.Search methodsWe searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied.Selection criteriaRandomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.Data collection and analysisTwo authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD).Main resultsWe included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review.Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I2 = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I2 = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m2) (-0.34 kg/m2, 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I2= 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I2 = 0%, low-quality evidence).Authors' conclusionsLifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.

Dataset Information

Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study.

Objective

Design

Setting

Patients

Interventions

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study.

Similar Datasets

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