Abstract
BackgroundDistinct molecular, inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites.MethodsThis single blinded randomized control trial will include 120 women with a BMI of 25–45 kg/m2, ≥21 years of age, and undergoing in vitro fertilization (IVF) treatments. Participants will be randomized to standard of care (N = 60) or an intervention group (N = 60) in a block design by polycystic ovary syndrome status. The intervention will combine a dietary component (Mediterranean meal plan) with exercise prescription following the Physical Activity Guidelines for Americans. Participants will be assessed pre- and post-intervention. The standard of care group will be offered to join the intervention group if the IVF treatments are unsuccessful as a cross over design. Recruitment is anticipated to start in July of 2021. Primary outcomes will include single oocyte gene expression profiles and follicular fluid metabolites. Mann-Whitney U nonparametric tests will be used to assess potential differences for each stratum. Follicular fluid and serum metabolites will be analyzed using a one-factor Analysis of Covariance (ANCOVA) at four levels, pair-wise comparisons using Tukey-Kramer post-hoc tests will be used to identify groups whose means differ significantly while retaining the family-wise error rate at 5%. When the design is balanced, two-way Analysis of Variance (ANOVA), or non-parametric Friedman test will be used in data analysis. Additionally, general linear models and ANCOVA may be used to control for covariates. Significance will be set at p < 0.05. Findings will be disseminated via peer-reviewed manuscripts and presentations at scientific conferences.DiscussionThis study will provide novel data and key information on the impact of a dietary and exercise intervention on oocyte gene expression and follicular fluid content. Results will demonstrate the potential of such intervention in mitigating obesity-induced changes in oocyte gene expression and follicular fluid metabolites.Trial registrationClinicalTrials.gov (NCT04273048): submitted November 13, 2019; posted February 17, 2020.
Highlights
Distinct molecular, inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases
Maternal obesity during pregnancy confers a major risk to offspring obesity [5], but less is known about the impact of peri-conception factors that influence metabolic programming
We have reported distinct molecular, inflammatory, and metabolic signatures in single oocytes and follicular fluid derived from obese women when compared to normal weight women preparing to undergo in vitro fertilization (IVF) [6]
Summary
Inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites. The Developmental Origins of Health and Disease (DOHaD) hypothesis suggests there are critical windows of development and growth, such as the in utero environment, that may significantly impact health for years to come through metabolic programing [1]. Undernutrition during this time alters metabolic tissues and systems in ways that confers vulnerability to cardiometabolic diseases such as metabolic syndrome [2]. Waist and hip circumferences will be measured to the nearest 0.1 cm using a tape measure against bare skin or form fitted shorts (tolerance of +/− 1 cm)
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