Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity

NCT07560579 | Active Not Recruiting

• 2 other identifiers: 202514801R43ES037592-01
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine the relationship in individuals with overweight/obesity and endocrine disrupting chemical (EDC) exposure through a two-armed, randomized clinical trial. The main questions this study aims to answer are:

1. 1.If MM's 12-week EDC intervention program (EDC testing and report-back, EDC reduction curriculum) can reduce weight?
2. 2.If a 12-week validated digital weight loss program can reduce EDC exposures?
3. 3.What is the effectiveness of the two interventions at reducing weight and urinary EDC metabolites? Participants will be assigned to one of these two arms. Participants will collect their urine and blood samples pre- and post-intervention, and will take a comprehensive exposure survey before sending back their samples. This exposure survey will ask about participant's weight loss literacy, environmental health literacy, product use, diet, and lifestyle behaviors.

Conditions

Environmental Exposure; Obesity &Amp;Amp;Amp; Overweight; Overweight (BMI > 25)

Keywords

EDCs; Weightloss; Endocrine Disrupting Chemicals; phthalates; bisphenols; parabens

Outcome Measures

Primary Outcomes (2)

• Changes in weight after intervention.

  EDC intervention that reduces EDC exposure also help individuals to lose weight. Comparing the two interventions to see which is more effective (EDC intervention or traditional weight loss intervention).

  Pre and post intervention (4 months between measurements)

• Changes in EDC metabolites after the intervention

  Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone

  Pre and post intervention (4 months in between measurements)

Secondary Outcomes (3)

• Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.

  Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

• Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.

  Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

• Changes in Weight Loss Literacy

  Measured before the intervention, after the intervention (4 months after baseline), and at follow-up (1 months after the intervention)

Study Arms (2)

Weight Loss Group

EXPERIMENTAL

Individuals will be recruited to this following the same eligibility and recruitment parameters of the EDC intervention group. The weight loss intervention group will use a weight loss application for 12 weeks. Participants will receive a MM test kit and Siphox kit at baseline, before starting the weight loss intervention, and after 12 weeks of engaging with the weight loss program. They will not undergo any EDC lifestyle auditing. Additionally, in order to reduce bias, these participants will not receive the results of their EDC testing and recommendations for reducing exposure until after the study has been completed, at which point they will receive both their baseline and post-intervention EDC exposure results.

Behavioral: Weight loss Application; Diagnostic Test: Urinary EDC metabolite testing; Diagnostic Test: Siphox clinic biomarker test; Diagnostic Test: Weight loss reporting

EDC Reduction Intervention Group

EXPERIMENTAL

Participants will be required to attend 2 food/product/lifestyle audit sessions, complete at least 6 out 12 of the modules in the intervention course and complete pre-post intervention surveys. Participants will be guided through this journey from our online instructions, online video tutorials, extensive educational materials, and email communication.

Behavioral: Educational curriculum; Diagnostic Test: Urinary EDC metabolite testing; Diagnostic Test: Siphox clinic biomarker test; Diagnostic Test: Weight loss reporting

Interventions

Educational curriculum BEHAVIORAL

A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.

EDC Reduction Intervention Group

Weight loss Application BEHAVIORAL

A paid, self-directed weight loss application.

Weight Loss Group

Urinary EDC metabolite testing DIAGNOSTIC_TEST

Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.

EDC Reduction Intervention Group; Weight Loss Group

Siphox clinic biomarker test DIAGNOSTIC_TEST

Mail-in blood samples tested for clinical biomarkers.

EDC Reduction Intervention Group; Weight Loss Group

Weight loss reporting DIAGNOSTIC_TEST

Self-reported weight loss.

EDC Reduction Intervention Group; Weight Loss Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI over 25
• Not pregnant or breast feeding
• Do not have diabetes, kidney disease, liver disease, cardiac disease, pulmonary disease or cancer.
• Do not smoke
• Not in another weight loss program or on GLP-1
• Have access to a smartphone or computer

You may not qualify if:

• BMI under 25
• Pregnant or breast feeding
• Have diabetes, kidney disease, liver disease, cardiac disease, pulmonary disease or cancer.
• Smoke
• In another weight loss program or on GLP-1
• Do not have access to a smartphone or computer

Sponsors & Collaborators

• Million Marker Wellness, Inc.: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Million Marker

Berkeley, California, 94704, United States

Location

Related Publications (56)

• Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group; Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5.

  PMID: 34863252 BACKGROUND

• Behr H, Earl S, Ho AS, Lee J, Mitchell ES, McCallum M, May CN, Michaelides A. Changes in Health-Promoting Behaviors and Their Association with Weight Loss, Retention, and Engagement on a Digital Program: Prospective Study. Nutrients. 2022 Nov 14;14(22):4812. doi: 10.3390/nu14224812.

  PMID: 36432498 BACKGROUND

• Carey A, Yang Q, DeLuca L, Toro-Ramos T, Kim Y, Michaelides A. The Relationship Between Weight Loss Outcomes and Engagement in a Mobile Behavioral Change Intervention: Retrospective Analysis. JMIR Mhealth Uhealth. 2021 Nov 8;9(11):e30622. doi: 10.2196/30622.

  PMID: 34747706 BACKGROUND

• Chin SO, Keum C, Woo J, Park J, Choi HJ, Woo JT, Rhee SY. Successful weight reduction and maintenance by using a smartphone application in those with overweight and obesity. Sci Rep. 2016 Nov 7;6:34563. doi: 10.1038/srep34563.

  PMID: 27819345 BACKGROUND

• Yilmaz B, Terekeci H, Sandal S, Kelestimur F. Endocrine disrupting chemicals: exposure, effects on human health, mechanism of action, models for testing and strategies for prevention. Rev Endocr Metab Disord. 2020 Mar;21(1):127-147. doi: 10.1007/s11154-019-09521-z.

  PMID: 31792807 BACKGROUND

• Vandiver KM, Erdei E, Mayer AG, Ricciardi C, O'Leary M, Burke K, Zelikoff JT. Building Environmental Health and Genomics Literacy among Healthcare Providers Serving Vulnerable Communities: An Innovative Educational Framework. Int J Environ Res Public Health. 2022 Jan 14;19(2):929. doi: 10.3390/ijerph19020929.

  PMID: 35055751 BACKGROUND

• Grindler NM, Allshouse AA, Jungheim E, Powell TL, Jansson T, Polotsky AJ. OBGYN screening for environmental exposures: A call for action. PLoS One. 2018 May 16;13(5):e0195375. doi: 10.1371/journal.pone.0195375. eCollection 2018.

  PMID: 29768418 BACKGROUND

• Finn S, O'Fallon L. The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. Environ Health Perspect. 2017 Apr;125(4):495-501. doi: 10.1289/ehp.1409337. Epub 2015 Jun 30.

  PMID: 26126293 BACKGROUND

• Lichtveld MY, Covert HH, Sherman M, Shankar A, Wickliffe JK, Alcala CS. Advancing Environmental Health Literacy: Validated Scales of General Environmental Health and Environmental Media-Specific Knowledge, Attitudes and Behaviors. Int J Environ Res Public Health. 2019 Oct 28;16(21):4157. doi: 10.3390/ijerph16214157.

  PMID: 31661913 BACKGROUND

• Rochester JR, Kwiatkowski CF, Neveux I, Dabe S, Hatcher KM, Lathrop MK, Daza EJ, Eskenazi B, Grzymski JJ, Hua J. A Personalized Intervention to Increase Environmental Health Literacy and Readiness to Change in a Northern Nevada Population: Effects of Environmental Chemical Exposure Report-Back. Int J Environ Res Public Health. 2024 Jul 11;21(7):905. doi: 10.3390/ijerph21070905.

  PMID: 39063482 BACKGROUND

• Liu G, Dhana K, Furtado JD, Rood J, Zong G, Liang L, Qi L, Bray GA, DeJonge L, Coull B, Grandjean P, Sun Q. Perfluoroalkyl substances and changes in body weight and resting metabolic rate in response to weight-loss diets: A prospective study. PLoS Med. 2018 Feb 13;15(2):e1002502. doi: 10.1371/journal.pmed.1002502. eCollection 2018 Feb.

  PMID: 29438414 BACKGROUND

• Song Y, Hauser R, Hu FB, Franke AA, Liu S, Sun Q. Urinary concentrations of bisphenol A and phthalate metabolites and weight change: a prospective investigation in US women. Int J Obes (Lond). 2014 Dec;38(12):1532-7. doi: 10.1038/ijo.2014.63. Epub 2014 Apr 11.

  PMID: 24722546 BACKGROUND

• van der Meer TP, Thio CHL, van Faassen M, van Beek AP, Snieder H, van Berkum FNR, Kema IP, Makris KC, Wolffenbuttel BHR, van Vliet-Ostaptchouk JV. Endocrine disrupting chemicals during diet-induced weight loss - A post-hoc analysis of the LOWER study. Environ Res. 2021 Jan;192:110262. doi: 10.1016/j.envres.2020.110262. Epub 2020 Oct 10.

  PMID: 33045228 BACKGROUND

• Cardenas A, Hauser R, Gold DR, Kleinman KP, Hivert MF, Fleisch AF, Lin PD, Calafat AM, Webster TF, Horton ES, Oken E. Association of Perfluoroalkyl and Polyfluoroalkyl Substances With Adiposity. JAMA Netw Open. 2018 Aug 3;1(4):e181493. doi: 10.1001/jamanetworkopen.2018.1493.

  PMID: 30646133 BACKGROUND

• Kim KY, Lee E, Kim Y. The Association between Bisphenol A Exposure and Obesity in Children-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 15;16(14):2521. doi: 10.3390/ijerph16142521.

  PMID: 31311074 BACKGROUND

• Trasande L, Attina TM, Blustein J. Association between urinary bisphenol A concentration and obesity prevalence in children and adolescents. JAMA. 2012 Sep 19;308(11):1113-21. doi: 10.1001/2012.jama.11461.

  PMID: 22990270 BACKGROUND

• Liu B, Lehmler HJ, Sun Y, Xu G, Sun Q, Snetselaar LG, Wallace RB, Bao W. Association of Bisphenol A and Its Substitutes, Bisphenol F and Bisphenol S, with Obesity in United States Children and Adolescents. Diabetes Metab J. 2019 Feb;43(1):59-75. doi: 10.4093/dmj.2018.0045.

  PMID: 30793552 BACKGROUND

• Li J, Zhang Z, Zhang C, Zhu Q, Zhao J, Zong H, Deng Q, Zheng J, Wu E, Wu R, Tang T, Zhang Y, Dong Q, Li Y, Wang J, Yang L, Qiu S, Shen B, Wei Q. Association Between Urinary Bisphenols and Body Composition Among American Adults: Cross-Sectional National Health and Nutrition Examination Survey Study. JMIR Public Health Surveill. 2023 Sep 19;9:e49652. doi: 10.2196/49652.

  PMID: 37615638 BACKGROUND

• Heindel JJ, Blumberg B. Environmental Obesogens: Mechanisms and Controversies. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:89-106. doi: 10.1146/annurev-pharmtox-010818-021304. Epub 2018 Jul 25.

  PMID: 30044726 BACKGROUND

• Kim JH, Kwak JM, Kang H. Web-based behavioral intervention to reduce exposure to phthalate metabolites, bisphenol A, triclosan, and parabens in mothers with young children: A randomized controlled trial. Int J Hyg Environ Health. 2021 Jul;236:113798. doi: 10.1016/j.ijheh.2021.113798. Epub 2021 Jun 23.

  PMID: 34186503 BACKGROUND

• Martin L, Zhang Y, First O, Mustieles V, Dodson R, Rosa G, Coburn-Sanderson A, Adams CD, Messerlian C. Lifestyle interventions to reduce endocrine-disrupting phthalate and phenol exposures among reproductive age men and women: A review and future steps. Environ Int. 2022 Dec;170:107576. doi: 10.1016/j.envint.2022.107576. Epub 2022 Oct 14.

  PMID: 36283156 BACKGROUND

• Corbett GA, Lee S, Woodruff TJ, Hanson M, Hod M, Charlesworth AM, Giudice L, Conry J, McAuliffe FM; International Federation of Gynecology and Obstetrics (FIGO) Committee on Impact of Pregnancy on Long-term Health and the FIGO Committee on Climate Change and Toxic Environmental Exposures. Nutritional interventions to ameliorate the effect of endocrine disruptors on human reproductive health: A semi-structured review from FIGO. Int J Gynaecol Obstet. 2022 Jun;157(3):489-501. doi: 10.1002/ijgo.14126. Epub 2022 Feb 23.

  PMID: 35122246 BACKGROUND

• Park J, Lee H, Lee S, Lee H. Interventions on Reducing Exposure to Endocrine Disrupting Chemicals in Human Health Care Context: A Scoping Review. Risk Manag Healthc Policy. 2022 Apr 26;15:779-791. doi: 10.2147/RMHP.S358561. eCollection 2022.

  PMID: 35502443 BACKGROUND

• Hagobian T, Smouse A, Streeter M, Wurst C, Schaffner A, Phelan S. Randomized Intervention Trial to Decrease Bisphenol A Urine Concentrations in Women: Pilot Study. J Womens Health (Larchmt). 2017 Feb;26(2):128-132. doi: 10.1089/jwh.2016.5746. Epub 2016 Oct 11.

  PMID: 27726525 BACKGROUND

• Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, Ackerman JM, Rizzo J, Nudelman JL, Brody JG. Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention. Environ Health Perspect. 2011 Jul;119(7):914-20. doi: 10.1289/ehp.1003170. Epub 2011 Mar 30.

  PMID: 21450549 BACKGROUND

• Vafeiadi M, Roumeliotaki T, Myridakis A, Chalkiadaki G, Fthenou E, Dermitzaki E, Karachaliou M, Sarri K, Vassilaki M, Stephanou EG, Kogevinas M, Chatzi L. Association of early life exposure to bisphenol A with obesity and cardiometabolic traits in childhood. Environ Res. 2016 Apr;146:379-87. doi: 10.1016/j.envres.2016.01.017. Epub 2016 Jan 25.

  PMID: 26821262 BACKGROUND

• Wang Z, Liu H, Liu S. Low-Dose Bisphenol A Exposure: A Seemingly Instigating Carcinogenic Effect on Breast Cancer. Adv Sci (Weinh). 2016 Nov 21;4(2):1600248. doi: 10.1002/advs.201600248. eCollection 2017 Feb.

  PMID: 28251049 BACKGROUND

• Meeker JD, Ferguson KK. Urinary phthalate metabolites are associated with decreased serum testosterone in men, women, and children from NHANES 2011-2012. J Clin Endocrinol Metab. 2014 Nov;99(11):4346-52. doi: 10.1210/jc.2014-2555. Epub 2014 Aug 14.

  PMID: 25121464 BACKGROUND

• Lehmler HJ, Liu B, Gadogbe M, Bao W. Exposure to Bisphenol A, Bisphenol F, and Bisphenol S in U.S. Adults and Children: The National Health and Nutrition Examination Survey 2013-2014. ACS Omega. 2018 Jun 30;3(6):6523-6532. doi: 10.1021/acsomega.8b00824. Epub 2018 Jun 18.

  PMID: 29978145 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Obstetric Practice. Reducing Prenatal Exposure to Toxic Environmental Agents: ACOG Committee Opinion, Number 832. Obstet Gynecol. 2021 Jul 1;138(1):e40-e54. doi: 10.1097/AOG.0000000000004449.

  PMID: 34259492 BACKGROUND

• Aung MT, Ferguson KK, Cantonwine DE, McElrath TF, Meeker JD. Preterm birth in relation to the bisphenol A replacement, bisphenol S, and other phenols and parabens. Environ Res. 2019 Feb;169:131-138. doi: 10.1016/j.envres.2018.10.037. Epub 2018 Nov 1.

  PMID: 30448626 BACKGROUND

• Monteiro CS, Xavier EBS, Caetano JPJ, Marinho RM. A critical analysis of the impact of endocrine disruptors as a possible etiology of primary ovarian insufficiency. JBRA Assist Reprod. 2020 Jul 14;24(3):324-331. doi: 10.5935/1518-0557.20200005.

  PMID: 32202399 BACKGROUND

• Rochester JR. Bisphenol A and human health: a review of the literature. Reprod Toxicol. 2013 Dec;42:132-55. doi: 10.1016/j.reprotox.2013.08.008. Epub 2013 Aug 30.

  PMID: 23994667 BACKGROUND

• Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Myers JP, DiGangi J, Hunt PM, Rudel R, Sathyanarayana S, Bellanger M, Hauser R, Legler J, Skakkebaek NE, Heindel JJ. Burden of disease and costs of exposure to endocrine disrupting chemicals in the European Union: an updated analysis. Andrology. 2016 Jul;4(4):565-72. doi: 10.1111/andr.12178. Epub 2016 Mar 22.

  PMID: 27003928 BACKGROUND

• Hiatt RA, Brody JG. Environmental Determinants of Breast Cancer. Annu Rev Public Health. 2018 Apr 1;39:113-133. doi: 10.1146/annurev-publhealth-040617-014101. Epub 2018 Jan 12.

  PMID: 29328875 BACKGROUND

• Machtinger R, Gaskins AJ, Racowsky C, Mansur A, Adir M, Baccarelli AA, Calafat AM, Hauser R. Urinary concentrations of biomarkers of phthalates and phthalate alternatives and IVF outcomes. Environ Int. 2018 Feb;111:23-31. doi: 10.1016/j.envint.2017.11.011. Epub 2017 Nov 20.

  PMID: 29161633 BACKGROUND

• Ghayda RA, Williams PL, Chavarro JE, Ford JB, Souter I, Calafat AM, Hauser R, Minguez-Alarcon L. Urinary bisphenol S concentrations: Potential predictors of and associations with semen quality parameters among men attending a fertility center. Environ Int. 2019 Oct;131:105050. doi: 10.1016/j.envint.2019.105050. Epub 2019 Jul 31.

  PMID: 31376593 BACKGROUND

• Marfella R, Prattichizzo F, Sardu C, Fulgenzi G, Graciotti L, Spadoni T, D'Onofrio N, Scisciola L, La Grotta R, Frige C, Pellegrini V, Municino M, Siniscalchi M, Spinetti F, Vigliotti G, Vecchione C, Carrizzo A, Accarino G, Squillante A, Spaziano G, Mirra D, Esposito R, Altieri S, Falco G, Fenti A, Galoppo S, Canzano S, Sasso FC, Matacchione G, Olivieri F, Ferraraccio F, Panarese I, Paolisso P, Barbato E, Lubritto C, Balestrieri ML, Mauro C, Caballero AE, Rajagopalan S, Ceriello A, D'Agostino B, Iovino P, Paolisso G. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. N Engl J Med. 2024 Mar 7;390(10):900-910. doi: 10.1056/NEJMoa2309822.

  PMID: 38446676 BACKGROUND

• Cardenas A, Hivert MF, Gold DR, Hauser R, Kleinman KP, Lin PD, Fleisch AF, Calafat AM, Ye X, Webster TF, Horton ES, Oken E. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Incident Diabetes and Microvascular Disease. Diabetes Care. 2019 Sep;42(9):1824-1832. doi: 10.2337/dc18-2254. Epub 2019 Jul 11.

  PMID: 31296647 BACKGROUND

• Hwang S, Lim JE, Choi Y, Jee SH. Bisphenol A exposure and type 2 diabetes mellitus risk: a meta-analysis. BMC Endocr Disord. 2018 Nov 6;18(1):81. doi: 10.1186/s12902-018-0310-y.

  PMID: 30400886 BACKGROUND

• Heindel JJ, Blumberg B, Cave M, Machtinger R, Mantovani A, Mendez MA, Nadal A, Palanza P, Panzica G, Sargis R, Vandenberg LN, Vom Saal F. Metabolism disrupting chemicals and metabolic disorders. Reprod Toxicol. 2017 Mar;68:3-33. doi: 10.1016/j.reprotox.2016.10.001. Epub 2016 Oct 17.

  PMID: 27760374 BACKGROUND

• Kassotis CD, Vom Saal FS, Babin PJ, Lagadic-Gossmann D, Le Mentec H, Blumberg B, Mohajer N, Legrand A, Munic Kos V, Martin-Chouly C, Podechard N, Langouet S, Touma C, Barouki R, Kim MJ, Audouze K, Choudhury M, Shree N, Bansal A, Howard S, Heindel JJ. Obesity III: Obesogen assays: Limitations, strengths, and new directions. Biochem Pharmacol. 2022 May;199:115014. doi: 10.1016/j.bcp.2022.115014. Epub 2022 Apr 5.

  PMID: 35393121 BACKGROUND

• Heindel JJ, Howard S, Agay-Shay K, Arrebola JP, Audouze K, Babin PJ, Barouki R, Bansal A, Blanc E, Cave MC, Chatterjee S, Chevalier N, Choudhury M, Collier D, Connolly L, Coumoul X, Garruti G, Gilbertson M, Hoepner LA, Holloway AC, Howell G 3rd, Kassotis CD, Kay MK, Kim MJ, Lagadic-Gossmann D, Langouet S, Legrand A, Li Z, Le Mentec H, Lind L, Monica Lind P, Lustig RH, Martin-Chouly C, Munic Kos V, Podechard N, Roepke TA, Sargis RM, Starling A, Tomlinson CR, Touma C, Vondracek J, Vom Saal F, Blumberg B. Obesity II: Establishing causal links between chemical exposures and obesity. Biochem Pharmacol. 2022 May;199:115015. doi: 10.1016/j.bcp.2022.115015. Epub 2022 Apr 5.

  PMID: 35395240 BACKGROUND

• Lustig RH, Collier D, Kassotis C, Roepke TA, Kim MJ, Blanc E, Barouki R, Bansal A, Cave MC, Chatterjee S, Choudhury M, Gilbertson M, Lagadic-Gossmann D, Howard S, Lind L, Tomlinson CR, Vondracek J, Heindel JJ. Obesity I: Overview and molecular and biochemical mechanisms. Biochem Pharmacol. 2022 May;199:115012. doi: 10.1016/j.bcp.2022.115012. Epub 2022 Apr 5.

  PMID: 35393120 BACKGROUND

• Hoppin JA, Brock JW, Davis BJ, Baird DD. Reproducibility of urinary phthalate metabolites in first morning urine samples. Environ Health Perspect. 2002 May;110(5):515-8. doi: 10.1289/ehp.02110515.

  PMID: 12003755 BACKGROUND

• Galloway TS, Baglin N, Lee BP, Kocur AL, Shepherd MH, Steele AM; BPA Schools Study Consortium; Harries LW. An engaged research study to assess the effect of a 'real-world' dietary intervention on urinary bisphenol A (BPA) levels in teenagers. BMJ Open. 2018 Feb 3;8(2):e018742. doi: 10.1136/bmjopen-2017-018742.

  PMID: 29431133 BACKGROUND

• Street ME, Bernasconi S. Endocrine-Disrupting Chemicals in Human Fetal Growth. Int J Mol Sci. 2020 Feb 20;21(4):1430. doi: 10.3390/ijms21041430.

  PMID: 32093249 BACKGROUND

• Hauser R, Skakkebaek NE, Hass U, Toppari J, Juul A, Andersson AM, Kortenkamp A, Heindel JJ, Trasande L. Male reproductive disorders, diseases, and costs of exposure to endocrine-disrupting chemicals in the European Union. J Clin Endocrinol Metab. 2015 Apr;100(4):1267-77. doi: 10.1210/jc.2014-4325. Epub 2015 Mar 5.

  PMID: 25742517 BACKGROUND

• Green MP, Harvey AJ, Finger BJ, Tarulli GA. Endocrine disrupting chemicals: Impacts on human fertility and fecundity during the peri-conception period. Environ Res. 2021 Mar;194:110694. doi: 10.1016/j.envres.2020.110694. Epub 2020 Dec 30.

  PMID: 33385395 BACKGROUND

• Braun JM. Early-life exposure to EDCs: role in childhood obesity and neurodevelopment. Nat Rev Endocrinol. 2017 Mar;13(3):161-173. doi: 10.1038/nrendo.2016.186. Epub 2016 Nov 18.

  PMID: 27857130 BACKGROUND

• Rattan, S. et al. (2017) "Exposure to Endocrine Disruptors during Adulthood: Consequences for Female Fertility." J. Endocrinol. 233(3): R109-R129. PMID: 28533420

  BACKGROUND

• Marlatt, V. L. et al. (2022) "Impacts of Endocrine Disrupting Chemicals on Reproduction in Wildlife and Humans." Environ. Res. 208: 112584. PMID: 34875313

  BACKGROUND

• Department of Error. Lancet. 2020 Jun 13;395(10240):1834. doi: 10.1016/S0140-6736(19)32947-2. No abstract available.

  PMID: 32534645 BACKGROUND

• Street ME, Angelini S, Bernasconi S, Burgio E, Cassio A, Catellani C, Cirillo F, Deodati A, Fabbrizi E, Fanos V, Gargano G, Grossi E, Iughetti L, Lazzeroni P, Mantovani A, Migliore L, Palanza P, Panzica G, Papini AM, Parmigiani S, Predieri B, Sartori C, Tridenti G, Amarri S. Current Knowledge on Endocrine Disrupting Chemicals (EDCs) from Animal Biology to Humans, from Pregnancy to Adulthood: Highlights from a National Italian Meeting. Int J Mol Sci. 2018 Jun 2;19(6):1647. doi: 10.3390/ijms19061647.

  PMID: 29865233 BACKGROUND

• Vandenberg LN, Colborn T, Hayes TB, Heindel JJ, Jacobs DR Jr, Lee DH, Shioda T, Soto AM, vom Saal FS, Welshons WV, Zoeller RT, Myers JP. Hormones and endocrine-disrupting chemicals: low-dose effects and nonmonotonic dose responses. Endocr Rev. 2012 Jun;33(3):378-455. doi: 10.1210/er.2011-1050. Epub 2012 Mar 14.

  PMID: 22419778 BACKGROUND

• Gore AC, Chappell VA, Fenton SE, Flaws JA, Nadal A, Prins GS, Toppari J, Zoeller RT. EDC-2: The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals. Endocr Rev. 2015 Dec;36(6):E1-E150. doi: 10.1210/er.2015-1010. Epub 2015 Nov 6.

  PMID: 26544531 BACKGROUND

Related Links

• National Report on Human Exposure to Environmental Chemicals; National Health and Nutrition Examination Survey (
• Million Marker
• Siphox Test

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Johanna R Rochester, PhD

  Million Marker Wellness

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Environmental Health Scientist

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: May 1, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting six months after publication
• Access Criteria: Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.

Locations

US (1)