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NCT Number: NCT07822230

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

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.

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Key information

Conditions

Menopause Body Weight Climactericum Menopause Hot Flashes Menopause Related Conditions Menopause Symptoms Menopause-related Hot Flashes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight , Obesity Pathological Conditions, Signs and Symptoms Perimenopause, Climacteric Syndrome Postmenopause Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

Location status: Recruiting

Location contact

Larissa V Nobre, RD

CONTACT

[email protected]

55+5192114435

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 40 to 65 years; in the perimenopausal or postmenopausal stage (based on clinical criteria and/or self-report) and exhibiting clinical symptoms characteristic of menopause; diagnosed as overweight or obese (BMI ≥ 25 kg/m²); having internet access via mobile phone or computer; and agreeing to participate by signing the Informed Consent Form (ICF).

Exclusion criteria

  • Pregnant women, women undergoing hormone replacement therapy or taking medications for obesity, diagnosed with active neoplasms undergoing chemotherapy or immunosuppressive treatment, and those with cognitive impairment.

Treatment and study plan

Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings

Other

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 material

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.

Primary outcomes

  1. Menopausal Symptoms

    Time frame: From the enrollment period to the end of the study: 5 months.

    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.

Secondary outcomes

  1. Dietary pattern

    Time frame: From the date of enrollment to the end of the intervention: 5 months

    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).

  2. Body mass index

    Time frame: From the date of enrollment to the end of the intervention: 5 months

    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.

  3. Waist circumference

    Time frame: From the date of enrollment to the end of the intervention: 5 months

    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.

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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