MenopauseNCT07822230
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
A study testing Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings and Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material in people with Menopause and Menopause Hot Flashes, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause, Menopause Hot Flashes, Overweight , Obesity
- What is being tested?
- Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings and Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2026to 30 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 to 65 years
- In the perimenopausal or postmenopausal stage (based on clinical criteria and/or self-report)
- Exhibiting clinical symptoms characteristic of menopause
- Diagnosed as overweight or obese (BMI ≥ 25 kg/m²)
- Internet access via mobile phone or computer
- Agreeing to participate by signing the Informed Consent Form (ICF)
Who cannot join
- Pregnancy
- Undergoing hormone replacement therapy
- Taking medications for obesity
- Diagnosed with active neoplasms undergoing chemotherapy or immunosuppressive treatment
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170
Larissa V Nobre, RD, 55+5192114435, larissa.nobre@gmail.com
About this study
The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity.
The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms.
A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.
- Conditions
- Menopause, Menopause Hot Flashes, Overweight , Obesity, Perimenopause, Climacteric Syndrome, Postmenopause, Menopause-related Hot Flashes
- Being tested
- Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings, Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material
- Keywords
- menopause, postmenopause, perimenopause, overweight, obesity, climacteric
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetingsOther
The intervention group will participate in five monthly Food and Nutrition Education sessions based on the Dietary Guidelines for the Brazilian Population. The first session will be an individual session on nutritional guidance, while the second will be a virtual group session on the NOVA food classification system. The third session will be a virtual group session on nutrition labeling. The fourth session will be a virtual group session on reducing culinary ingredients (salt, sugar, and fat) in food preparation. The fifth session will be an in-person group cooking workshop focused on preparing healthy and practical recipes.
Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed materialOther
The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study. The guidance will be standardized, with no individual follow-up or in-person meetings.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | Other | The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study. The guidance will be standardized, with no individual follow-up or in-person meetings. Receives: Other: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material |
| Intervention group (IG) | Active comparator | The intervention group will receive nutritional guidance on healthy eating, based on the Dietary Guidelines for the Brazilian Population, provided via printed materials and five monthly in-person sessions. Receives: Other: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal Symptoms
Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period. Menopausal symptom intensity, measured using the Menopause Rating Scale (MRS) questionnaire, will be the primary outcome indicator. This instrument assesses 11 symptoms on a scale of 0 to 4, where 0 indicates no complaints, 1 mild, 2 moderate, 3 severe, and 4 very severe, with a maximum possible score of 44 points.
Measured: From the enrollment period to the end of the study: 5 months.
Secondary outcomes (3)
Dietary pattern
Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period. Dietary patterns will be assessed using the NOVA 24-Hour Dietary Recall, based on data regarding food intake from the previous day. This tool was developed by the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo (USP) on the QUEST NOVA platform-available at https://www.fsp.usp.br/nupens/quest-nova/-and classifies foods according to their degree of processing based on the NOVA classification system. The results show total caloric intake categorized into four groups: Group 1 (unprocessed or minimally processed foods), Group 2 (culinary ingredients), Group 3 (processed foods), and Group 4 (ultra-processed foods).
Measured: From the date of enrollment to the end of the intervention: 5 months
Body mass index
Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period. The BMI (Body Mass Index) classification is calculated by dividing body weight (kg) by height (m) squared and is used to classify nutritional status according to WHO standards.
Measured: From the date of enrollment to the end of the intervention: 5 months
Waist circumference
Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period. Waist circumference will be measured, with the participant standing, at the end of a normal exhalation, with an inelastic and non-extensive anthropometric tape surrounding the abdominal region at the midpoint between the lower edge of the last rib and the iliac crest. Measurements will be taken in duplicate and recorded in centimeters on the data collection form. The average will be used to classify metabolic risk, with a cutoff point of 88 cm for women.
Measured: From the date of enrollment to the end of the intervention: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start6 May 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group clinical trial with a 1:1 allocation ratio comparing a dietary intervention based on the Dietary Guidelines for the Brazilian Population with the control intervention.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Profª Drª Fernanda Michielin Busnello, Federal University of Health Science of Porto Alegre
- Investigators
- Fernanda M Busnello, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822230
- Sponsor's protocol ID
- CAAE93638725.5.3001.5345
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conselho Nacional de Saúde (Brasil). Resolução nº 466, de 12 de dezembro de 2012: diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Brasília (DF): Ministério da Saúde; 2012
World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants. [S.l.]: World Medical Association; 2024. https://www.wma.net/policies-post/wma-declaration-of-helsinki
Organização Mundial da Saúde. Boas práticas clínicas: documento das Américas, República Dominicana, 2-4 de março de 2005
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
PubMed 19897823Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Am J Clin Nutr. 1998 Oct;68(4):899-917. doi: 10.1093/ajcn/68.4.899. No abstract available.
PubMed 9771869World Health Organization (WHO). Body mass index - BMI [Internet]. Geneva: WHO. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Acesso em: 05 Aug 2025
Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Orientações para a coleta e análise de dados antropométricos em serviços de saúde: norma técnica do Sistema de Vigilância Alimentar e Nutricional - SISVAN. Brasília: Ministério da Saúde; 2011. 76 p. (Série G. Estatística e Informação em Saúde). https://bvsms.saude.gov.br/bvs/publicacoes/orientacoes_coleta_analise_dados_antropometricos.pdf. Acesso em: 05 Aug 2025
National Institute on Drug Abuse. Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Questionnaire. NIH Common Data Element Repository; 2015. Disponível em: https://cde.nlm.nih.gov/formView?tinyId=myWNfJaZwe. Acesso: 15 Aug. 2025
Matsudo S, Araújo T, Matsudo V, Andrade D, Andrade E, Oliveira LC, et al. Questionário Internacional de Atividade Física (IPAQ): estudo de validade e reprodutibilidade no Brasil. Rev Bras Ativ Fís Saúde. 2001;6(2):5-18
BRASIL. Ministério da Saúde. Universidade de São Paulo. Manual instrutivo: implementando o Guia Alimentar para a População Brasileira. Brasília: Ministério da Saúde; 2019. http://189.28.128.100/dab/docs/portaldab/publicacoes/manual_instrutivo_guia_alimentar_pop_brasileira.pdf
Brasil. Ministério da Saúde; Universidade Federal de Minas Gerais. Instrutivo: Metodologia de trabalho em grupos para ações de alimentação e nutrição na atenção básica. Brasília: Ministério da Saúde; 2016
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
PubMed 21350618Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Brasil. Ministério da Saúde; Universidade de São Paulo, Núcleo de Pesquisas Epidemiológicas em Nutrição e Saúde (Nupens). Fascículo 1: Protocolos de uso do Guia Alimentar para a População Brasileira na orientação alimentar: bases teóricas e metodológicas e protocolo para a população adulta. Brasília: Ministério da Saúde; 2021. https://www.fsp.usp.br/nupens/