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Normast3 for Adults With Diabetic Polyneuropathy

2026年6月30日 更新者：Andrea Truini、University of Roma La Sapienza

A Randomized, Placebo-Controlled, Double-Blind, Single-Center Clinical Trial to Evaluate the Efficacy of Normast3 in Adult Patients With Diabetic Polyneuropathy

The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate.

The main questions this study aims to answer are:

Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends.

Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part.

What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time.

Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating Normast® 3 as add-on treatment in adults with diabetic polyneuropathy involving both small and large nerve fibers. The study is designed to assess whether 12 weeks of treatment with Normast® 3 improves neuropathic pain and selected clinical, psychophysical, autonomic, and morphometric markers of nociceptive and autonomic nerve fiber function compared with placebo.

Approximately 40 participants will be randomized in a 1:1 ratio to receive either Normast® 3 or matching placebo for 12 weeks, while continuing stable standard-of-care treatment. Study assessments are performed at baseline, at the end of the 12-week treatment period, and at a 24-week follow-up visit to evaluate persistence of treatment effects.

The study population includes adults with diabetic polyneuropathy characterized by symptoms and signs of distal sensory involvement and objective evidence of large- and small-fiber abnormalities. Neurological assessment includes evaluation of negative sensory signs, such as tactile, pinprick, and thermal hypoesthesia, and positive sensory signs, such as spontaneous pain, paroxysmal pain, allodynia, and pinprick hyperalgesia. Quantitative sensory testing is performed at the foot to assess thermal, mechanical, pain, pressure, paradoxical heat, and vibration-related sensory parameters.

Autonomic nervous system function is assessed using sudomotor and cardiovascular autonomic testing. Sudomotor function is evaluated through quantitative assessment of activated sweat glands at the distal leg. Cardiovascular autonomic testing includes heart-rate and blood-pressure responses at rest, during paced deep breathing, standing, the Valsalva manoeuvre, and sustained handgrip.

Skin biopsy is used to assess small-fiber and autonomic innervation. Samples are obtained from standardized distal and proximal sites and processed using immunofluorescence methods. Morphometric analyses include intraepidermal nerve fiber density, distal-to-proximal nerve fiber density ratio, sweat gland and piloerector muscle autonomic innervation density, and expression patterns of selected nociceptor-related skin biomarkers.

Normast® 3 contains palmitoylethanolamide co-micronized with rutin and hydroxytyrosol. The active product and placebo are prepared to be indistinguishable in appearance and administered twice daily. Treatment allocation is concealed from participants and study personnel until completion of the blinded phase, except when unblinding is required for safety reasons.

Safety and tolerability are assessed through clinical monitoring, vital signs, laboratory testing, and adverse-event collection during the treatment period. Compliance is assessed by return of used treatment packs at study visits. The total observation period for each participant is approximately 6 months, and the overall study duration is estimated to be approximately 18 months.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Diagnosis of mixed-fiber diabetic polyneuropathy Provision of signed and dated informed consent Willingness to comply with all study procedures and availability for the duration of the study Male or female participants aged 18 to 80 years Ability to take oral medication Stable pharmacological treatment during the 3 months before enrollment

Exclusion Criteria:

Concomitant peripheral or central nervous system disease that could interfere with the study objectives Conditions other than diabetes that could affect the peripheral nervous system, including vitamin B12 deficiency, kidney failure, previous neurotoxic therapies, thyroid disease, autoimmune diseases, or familial amyloidosis Cognitive impairment Major psychiatric comorbidities Inflammatory rheumatic diseases Pain due to conditions other than diabetic polyneuropathy Clinically significant disease or condition that could affect efficacy or safety assessments or otherwise preclude study participation, in the investigator's judgment Evidence or history of alcohol or drug abuse, including opioids, amphetamines, benzodiazepines, or cannabinoids Known or suspected unwillingness or inability to comply with the trial protocol or study instructions Inability to communicate meaningfully with trial site staff, including insufficient language skills Pregnancy or lactation Any other reason for exclusion according to the investigator's judgment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Normast3
Participants will receive Normast® 3 tablets twice daily, after lunch and after dinner, for 12 weeks, in addition to standard diabetes care.
ダイエットサプリメント：Normast® 3 - a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin and hydroxytyrosol. It is designed to support the management of diabetic polyneu
Normast® 3 is a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin (5:1) and hydroxytyrosol. Each tablet provides 360 mg PEA/rutin and 15 mg hydroxytyrosol. The product is formulated to target neuroinflammation and vascular dysfunction involved in diabetic polyneuropathy. In this study, participants will take one tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.
プラセボコンパレーター：placebo
Participants will receive placebo tablets twice daily, after lunch and after dinner, for 12 weeks, in addition to standard diabetes care.
ダイエットサプリメント：Placebo
Placebo tablets are visually and taste-matched to Normast® 3 but contain no active ingredients. Each tablet is composed of inert excipients (mainly microcrystalline cellulose and other standard tablet components). Participants will take one placebo tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in average daily pain intensity
時間枠：Time Frame: Baseline to Week 12

Description: Change from baseline to Week 12 in the weekly average of participants' daily pain intensity scores, measured using the 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst possible pain.

Safety Issue: No
Time Frame: Baseline to Week 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in autonomic system function (sweat glands) at Week 12
時間枠：Baseline to Week 12
Percentage change from baseline in the number of activated sweat glands, assessed with sudomotor function testing (volume of sweat produced expressed as mcl/cm2/min), in the Normast® 3 group compared to the placebo group.
Baseline to Week 12
Change in R-R variability at rest Week 12
時間枠：Baseline to Week 12
Percentage change from baseline in R-R variability at rest after treatment (expressed as total heart rate variability power in milliseconds squared), comparing the Normast® 3 group to the placebo group.
Baseline to Week 12
Change in autonomic innervation density at Week 12
時間枠：Baseline to Week 12
Percentage change from baseline in piloerector muscle autonomic innervation density, measured by skin biopsy and immunostaining, in the Normast® 3 group compared to the placebo group.
Baseline to Week 12
Change in autonomic system function (sweat glands) at Week 24
時間枠：Baseline to Week 24
Percentage change from baseline in the number of activated sweat glands, assessed with sudomotor function testing (volume of sweat produced expressed as mcl/cm2/min), in the Normast® 3 group compared to the placebo group.
Baseline to Week 24
Change in clinical sensory testing outcomes at Week 12
時間枠：Baseline to Week 12
Change from baseline in QST sensory profile in the Normast® 3 group compared to the placebo group.
Baseline to Week 12
Change in R-R variability during deep breathing at Week 12
時間枠：Baseline to week 12
Percentage change from baseline in R-R variability during paced deep breathing (expressed as difference in heart rate between maximum inspiration and minimum expiration), after treatment, comparing the Normast® 3 group to the placebo group.
Baseline to week 12
Change in Valsalva ratio at Week 12
時間枠：Baseline to week 12

Change from baseline in Valsalva ratio. Valsalva ratio is a cardiovascular autonomic test measure used to assess parasympathetic/vagal heart-rate control.

It is calculated during the Valsalva manoeuvre as:

Valsalva Ratio = Maximum Heart Rate During/Immediately After Straining ÷ Minimum Heart Rate After Release
Baseline to week 12
Change LF/HF ratio
時間枠：Baseline to 12 week
Change from baseline in LF/HF ratio, derived from ECG R-R interval recordings after treatment compared to placebo
Baseline to 12 week

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Patient Global Impression of Change (PGIC) at Week 12
時間枠：Baseline to Week 12
Percentage of participants in the Normast® 3 group reporting an improvement of at least 2 points on the Patient Global Impression of Change (PGIC) (a 7-point patient-rated scale assessing perceived change in overall condition, ranging from 1 = very much improved to 7 = very much worse) scale at Week 12, compared to the placebo group.
Baseline to Week 12
Change in Patient Global Impression of Change (PGIC) at Week 24
時間枠：Baseline to Week 24
Percentage of participants in the Normast® 3 group reporting an improvement of at least 2 points on the Patient Global Impression of Change (PGIC) (a 7-point patient-rated scale assessing perceived change in overall condition, ranging from 1 = very much improved to 7 = very much worse) scale at Week 24, compared to the placebo group.
Baseline to Week 24
Percentage of patients achieving Pain reduction ≥50% at Week 12
時間枠：Baseline to Week 12
Percentage of participants achieving at least 50% reduction in average daily pain intensity (on a numerical rating scale from 0 to 10) from baseline at Week 12 in the Normast® 3 group, compared to the placebo group.
Baseline to Week 12
Percentage of patients achieving Pain reduction ≥50% at Week 24
時間枠：Baseline to Week 24
Percentage of participants achieving at least 50% reduction in average daily pain intensity(on a numerical rating scale from 0 to 10) from baseline at Week 24 in the Normast® 3 group, compared to the placebo group.
Baseline to Week 24
Percentage of patients achieving Pain reduction ≥30% at Week 12
時間枠：Baseline to Week 12
Percentage of participants achieving at least 30% reduction in average daily pain intensity (on a numerical rating scale from 0 to 10) from baseline at Week 12 in the Normast® 3 group, compared to the placebo group
Baseline to Week 12
Percentage of patients achieving Pain reduction ≥30% at Week 24
時間枠：Baseline to Week 24
Percentage of participants achieving at least 30% reduction in average daily pain intensity (on a numerical rating scale from 0 to 10) from baseline at Week 24 in the Normast® 3 group, compared to the placebo group.
Baseline to Week 24

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Roma La Sapienza

捜査官

  • 主任研究者：andrea truini, full professor、department of human neuroscience, sapienza university

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年7月17日

一次修了 (推定)

2026年7月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年6月30日

最初の投稿 (実際)

2026年7月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月8日

QC基準を満たした最後の更新が送信されました

2026年6月30日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NORM3_DPN

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

De-identified individual participant data (IPD) underlying the study results (including text, tables, figures, and appendices) might be made available to qualified researchers upon reasonable request to the sponsor, after publication of the primary study results. Data will be shared for purposes of meta-analyses or other scientific research, in compliance with applicable data protection regulations.

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いいえ

米国FDA規制機器製品の研究

いいえ

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