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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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

  • 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

    Recruiting

Other trials in Brazil

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.

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 groups in NCT07822230
Study groupRoleWhat they receive
Control group (CG)OtherThe 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 comparatorThe 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted16 Sep 2026
  2. Study start6 May 2026
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

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)
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 19897823

  • Faul 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 17695343

  • Clinical 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 9771869

  • World 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 21350618

  • Chan 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 23303884

  • Brasil. 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/

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopausal Symptoms (time frame: From the enrollment period to the end of the study: 5 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07822230, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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