Evidence map›Paper›PMID 40749967›Full record

Trial reportThe American journal of clinical nutrition2025

Sex hormone changes in a 24-mo dietary and physical activity randomized intervention trial in postmenopausal females: the Diet, physical Activity and Mammography study (DAMA) study.

Benedetta Bendinelli, Giovanna Danza, Melania Assedi, Fabio Villanelli, Giulia Vagnoni, Elisa Pastore, Ilaria Ermini, Calogero Saieva, Saverio Caini, Sara Marchiani and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Benedetta BendinelliClinical Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Giovanna DanzaDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy.
Melania AssediCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Fabio VillanelliDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy.
Giulia VagnoniClinical Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Elisa PastoreClinical Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Ilaria ErminiCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Calogero SaievaCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Saverio CainiCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
Sara MarchianiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy.
Linda VignozziDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy; Centro Regionale di Coordinamento Salute e Medicina di Genere (CISMEG), Careggi University Hospital, Florence, Italy.
Giovanna MasalaClinical Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy. Electronic address: g.masala@ispro.toscana.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of sex steroid hormones in the etiology of several diseases, including breast and endometrial cancer, has been widely documented. In postmenopausal females, higher concentrations of estrogens and androgens are associated with a higher risk of developing breast cancer. It is therefore important to investigate whether and how diet and physical activity (PA) can modulate sex hormone blood concentrations.

objectivesWe evaluated the effect of a 24-mo dietary and/or PA intervention on plasma concentrations of a series of sex hormones.

methodsThe 234 study participants were healthy postmenopausal females aged 50-69 y, with high breast density, nonsmokers, and no hormone replacement therapy users. They were randomly assigned to the following 4 intervention arms: 1) isocaloric dietary intervention, mainly plant-based; 2) moderate-intensity exercise intervention with ≥1 h/wk of supervised strenuous activity; 3) both dietary and exercise interventions; 4) control group with general recommendations on healthy lifestyle. In plasma samples collected at baseline and at the end of the intervention, concentrations of estradiol, estrone, progesterone, 17-OH progesterone, testosterone, androstenedione, dehydroepiandrosterone, and dehydroepiandrosterone sulfate were determined by liquid chromatography tandem mass spectrometry methods. Sex hormone-binding globulin was determined by immunoassay, and free estradiol and testosterone were calculated using the Vermeulen method. Statistical analyses were performed using Tobit regression models.

resultsAfter 24 mo, females randomly assigned to dietary treatment (arms 1 + 3) showed significant lower concentrations of estradiol [exp(β) 0.77; 95% confidence interval (CI): 0.61, 0.97; P value 0.03] and free estradiol (exp(β) 0.81; 95% CI: 0.65, 0.998; P value 0.048) compared with the control group (arms 2 + 4). No significant differences emerged for the other sex hormones. No effect of PA intervention was evident. Further adjustment for weight change that occurred during the intervention did not modify the results.

conclusionsOur results suggest that, in healthy postmenopausal females with high breast density, a healthy diet mainly based on plant food may play a role as a modulator of plasma estradiol concentration. This trial was registered at the ISRCTN Registry (www.isrctn.com) as ISRCTN28492718.

Indexed as

DietExerciseGonadal Steroid HormonesPostmenopauseAgedDehydroepiandrosteroneEstradiolEstroneFemaleHumansMammographyMiddle AgedSex Hormone-Binding GlobulinTestosteroneDehydroepiandrosteroneEstradiolEstroneGonadal Steroid HormonesSex Hormone-Binding GlobulinTestosteronedietphysical activitypostmenopausal femalesrandomized intervention trialSex hormonesSHBG

Identifiers

PMID40749967
PMCPMC12674079

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.