Evidence map›Paper›PMID 27525817›Full record

ArticleNutrition & diabetes2016

A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes.

A Soare, R Del Toro, Y M Khazrai, A Di Mauro, S Fallucca, S Angeletti, E Skrami, R Gesuita, D Tuccinardi, S Manfrini and 3 more

Abstract read
In one paragraph

Article in Nutrition & diabetes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
–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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Trial
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  7. Review
  8. Article
  9. Beyond Plants: The Ultra-Processing of Global Diets Is Harming the Health of People, Places, and Planet.International journal of environmental research and public health · 2023
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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

13 authors.

A SoareUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
R Del ToroUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
Y M KhazraiUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
A Di MauroUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.ORCID 0000-0002-6844-5108
S FalluccaUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
S AngelettiDepartment of Laboratory Medicine, University Campus Bio-Medico of Rome, Rome, Italy.
E SkramiCenter of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Ancona, Italy.ORCID 0000-0001-7940-6748
R GesuitaCenter of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Ancona, Italy.
D TuccinardiUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
S ManfriniUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
F FalluccaDepartment of Clinical Sciences, La Sapienza University II Faculty, Rome, Italy.
M PianesiInternational Study Center for Environment, Agriculture, Food, Health and Economics, Tolentino, Italy.
P PozzilliUnit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. SUBJECTS: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27-45 kg m(-2); age, 40-75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel.

resultsA significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (-11.27% (95% confidence interval (CI): -10.17; -12.36)) compared with the control group (-5.88% (95% CI: -3.79; -7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI: 2.56; 7.61) and body weight (95% CI: 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI: -1.52; -33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl(-1) and <100 mg dl(-1), respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol(-1))) at 6 months.

conclusionsBoth the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow-up in real-world conditions. The Ma-Pi diet resulted in greater improvement in glycemic control.

Indexed as

Diet, MacrobioticAdultAgedBlood GlucoseDiabetes Mellitus, Type 2Follow-Up StudiesGlycated HemoglobinHumansLipidsMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeBlood GlucoseGlycated HemoglobinLipids

Identifiers

PMID27525817
PMCPMC5022142

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Registered trials

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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 OpenQuestion graph.