Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (Ancestry)
2026年5月14日 更新者：Juan Armendáriz-Borunda, PhD, FAASLD、University of Guadalajara
Effect of Ancestry Supplementation on the Abundance of Beneficial Bacterial Genera in the Gut Microbiota in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The goal of this clinical trial is to evaluate the effect of Ancestry, a supplement made from Mexican-origin foods (nopal, cacao, and cricket) in adults with Metabolic dysfunction-associated steatotic liver disease (MASLD). The main questions it aims to answer are:
- Does the supplementation with Ancestry improve the hepatic steatosis grade in participants with MASLD?
- Does the supplementation improve biochemical and anthropometric parameters in participants with MASLD?
- Does the supplementation enrich the abundance of beneficial bacteria in the gut microbiota of participants?
Researchers will compare the supplement group to a placebo group to see if the supplement is effective.
Participants will:
- Take the supplement or a placebo every day for 3 months.
- Receive nutritional guidance from a trained dietitian to control dietary intake.
- Attend follow-up clinic visits every month for monitoring and checkups.
調査の概要
詳細な説明
The study will follow a randomized double-blind design. Randomization will be performed in matched pairs according to sex, age (±3 years), diabetes status, body mass index (BMI), and degree of hepatic steatosis. An investigator not involved in participant follow-up will generate a coded randomization list to assign participants to the supplement or placebo group.
Investigators involved in participant assessments and sample processing, as well as study participants, will remain blinded to group allocation throughout the intervention. The supplement and placebo will be provided in identical packaging to maintain blinding.
Hepatic steatosis and fibrosis will be evaluated using the FibroScan Expert 630 device (Echosens, Paris, France), a vibration-controlled transient elastography (VCTE) system, by a physician specialized in hepatology and gastroenterology.
Nutritional consultations and dietary prescriptions will be provided by a trained nutritionist following the clinical recommendations established by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) for MASLD management.
Anthropometric assessment will include height and waist, abdominal, and hip circumferences measured using a Lufkin Rosscraft W606 metallic measuring tape. Body composition analysis will be performed using the InBody 720 bioimpedance analyzer (Biospace), which will provide measurements of body weight, body fat percentage, and visceral fat. All measurements will be interpreted according to standardized guidelines and reference cut-off values.
研究の種類
介入
入学 (推定)
60
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。
研究場所
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Guadalajara
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Guadalajara、Guadalajara、メキシコ、44340
- Institute of Molecular Biology in Medicine and Gene Therapy
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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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Mexican mestizo adults of both sexes between 18 to 60 years old
- Diagnosis of MASLD according to the criteria established by the American Association for the Study of Liver Diseases
- Controlled Attenuation Parameter (CAP) score >248 dB/m, liver stiffness <14 kPa according to FibroScan Expert 630 (Echosens, Paris, France)
- Obesity diagnosed by body fat percentage
- Bristol stool scale type 3-4
- Physical inactivity according to the International Physical Activity Questionnaire (IPAQ)
- Alcohol consumption <20 grams/day for women and <30 grams/day for men
- Signed informed consent
Exclusion Criteria:
- Severe gastrointestinal diseases (e.g., chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, etc.), autoimmune diseases, and malignant neoplasms
- Current or prior 6 weeks consumption of probiotic formulations
- Current or prior 2 months consumption of antibiotics or antiparasitic drugs before the start of the study
- Current consumption of dietary supplements (omega-3 fatty acids, thermogenics, protein, teas, etc.)
- Frequent consumption (greater than or equal to twice a week) of anti-inflammatory drugs, analgesics, or medications that alter normal intestinal function (e.g., laxatives, enemas, antidiarrheal agents, etc.)
- Pregnant women, women planning pregnancy, or breastfeeding women
- Weight loss greater than three kilograms in the last month
- Tobacco consumption
- Allergy or intolerance to cacao, nopal, or crickets
- Previous malabsorptive bariatric surgery (gastric bypass, sleeve gastrectomy), restrictive bariatric surgery (adjustable gastric band), or cosmetic surgical procedures (liposuction, lipo-sculpture, abdominoplasty, etc.) in the last 2 years
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Ancestry Group
Participants in this arm will receive a daily supplement containing a mixture of Mexican-origin foods (nopal, cacao, and cricket) for 3 months.
The supplement is named Ancestry.
Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.
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The active intervention consists of a daily oral supplement in powder form, containing a 30g mixture of dehydrated Mexican-origin foods: nopal (10g), cocoa powder (10g), and cricket (10g).
The supplement will be consumed once daily for 3 months.
Participants will be instructed to mix the entire 30g powder content with 250 ml of water and consume it immediately.
他の名前：
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プラセボコンパレーター：Placebo Group
Participants in this arm will receive a daily placebo supplement that is identical in appearance to the experimental supplement but without the active ingredients.
Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.
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The placebo consists of a daily oral supplement in powder form, containing a mixture of calcium caseinate (10g) and maltodextrin (5g).
This matched formulation is designed to equalize the caloric value and macronutrient profile of the active intervention.
The placebo will be consumed once daily for 3 months.
Participants will be instructed to mix the entire powder content with 250 ml of water and consume it immediately.
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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 |
|---|---|---|
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A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
時間枠：From enrollment to the end of treatment at 12 weeks
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Hepatic steatosis will be assessed using the Controlled Attenuation Parameter (CAP) score in dB/m, where higher values indicate greater hepatic fat accumulation. Steatosis grades will be classified as follows: S0 <248 dB/m, S1 248-268 dB/m, S2 269-280 dB/m, and S3 >280 dB/m. Improvement will be defined as a reduction of at least one steatosis grade according to these CAP cut-off values. Hepatic fibrosis will be classified according to liver stiffness measurement (LSM) values obtained by Vibration-Controlled Transient Elastography. LSM will be reported in kilopascals (kPa), where higher values indicate greater fibrosis severity. Fibrosis stages will be defined as follows: F0 <6.5 kPa, F1 6.5-7.2 kPa, F2 7.3-9.5 kPa, F3 9.6-14.5 kPa, and F4 >14.5 kPa. Worsening of liver fibrosis will be defined as an increase of at least one fibrosis stage. |
From enrollment to the end of treatment at 12 weeks
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Increase in Alpha Diversity and/or Enrichment of Beneficial Bacterial Genera in the Gut Microbiota
時間枠：From baseline to the end of treatment at 12 weeks
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Gut microbiota composition will be assessed through 16S rRNA gene sequencing of stool samples collected at baseline and after the intervention.
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From baseline to the end of treatment at 12 weeks
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Achieving a clinically significant reduction in total body weight by at least 3%
時間枠：From baseline to the end of treatment at 12 weeks
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Total body weight will be measured using the InBody 720 bioelectrical impedance analyzer (Biospace, South Korea), following standard procedures (fasting state, empty bladder, light clothing).
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From baseline to the end of treatment at 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
時間枠：From baseline to the end of treatment at 12 weeks
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Liver fibrosis will be assessed non-invasively via liver stiffness measurement (LSM) in kilopascals (kPa) using Vibration-Controlled Transient Elastography (FibroScan Expert 630, Echosens).
Improvement is defined as a reduction of at least 1 fibrosis stage according to established kPa cut-off values.
This improvement must occur without concurrent worsening of hepatic steatosis, defined as an increase in grade according to Controlled Attenuation Parameter (CAP) values.
Both measurements will be performed simultaneously using the same device.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Body Mass Index (BMI)
時間枠：From baseline to the end of treatment at 12 weeks
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Body mass index will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Higher values indicate greater obesity severity.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Body Fat Percentage
時間枠：From baseline to the end of treatment at 12 weeks
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Body Fat Percentage will be assessed using the InBody 720 bioelectrical impedance analyzer.
Values range from 0 to 100%, with higher values indicating greater adiposity.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Visceral Fat Level
時間枠：From baseline to the end of treatment at 12 weeks
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Visceral fat level will be evaluated using the InBody 720 bioelectrical impedance analyzer.
Higher values indicate greater visceral adiposity.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Waist Circumference
時間枠：From baseline to the end of treatment at 12 weeks
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Waist circumference will be measured in centimeters using a Lufkin Rosscraft W606 metallic measuring tape at the midpoint between the lowest rib and the iliac crest.
Higher values indicate greater central adiposity.
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From baseline to the end of treatment at 12 weeks
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Improvement in total cholesterol levels
時間枠：From baseline to the end of treatment at 12 weeks
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Serum total cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater metabolic risk.
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From baseline to the end of treatment at 12 weeks
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Improvement in total triglyceride levels
時間枠：From baseline to the end of treatment at 12 weeks
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Serum triglyceride levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater metabolic risk.
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From baseline to the end of treatment at 12 weeks
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Improvement in High-Density Lipoprotein Cholesterol (HDL-C)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum HDL-C levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate a more favorable lipid profile.
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From baseline to the end of treatment at 12 weeks
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Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum LDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater metabolic risk.
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From baseline to the end of treatment at 12 weeks
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Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum VLDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater metabolic risk.
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From baseline to the end of treatment at 12 weeks
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Improvement in Alanine Aminotransferase (ALT)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum alanine aminotransferase (ALT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater liver injury.
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From baseline to the end of treatment at 12 weeks
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Improvement in Aspartate Aminotransferase (AST)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum aspartate aminotransferase (AST) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater liver injury.
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From baseline to the end of treatment at 12 weeks
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Improvement in Gamma-glutamyl transferase (GGT)
時間枠：From baseline to the end of treatment at 12 weeks
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Serum Gamma-glutamyl transferase (GGT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate greater liver injury.
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From baseline to the end of treatment at 12 weeks
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Improvement in Fasting Glucose
時間枠：From baseline to the end of treatment at 12 weeks
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Fasting serum glucose levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics).
Higher values indicate poorer glycemic control.
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From baseline to the end of treatment at 12 weeks
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Improvement in Fasting Insulin
時間枠：From baseline to the end of treatment at 12 weeks
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Fasting serum insulin concentrations will be measured in µIU/mL by chemiluminescence immunoassay using the Liaison platform (Diasorin).
Higher values indicate greater insulin resistance.
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From baseline to the end of treatment at 12 weeks
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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。
協力者
捜査官
- 主任研究者：Juan Armendáriz-Borunda, PhD, FAASLD、University of Guadalajara
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
- Rosas-Campos R, Sandoval-Rodriguez AS, Rodriguez-Sanabria JS, Vazquez-Esqueda AO, Alfaro-Martinez CR, Escutia-Gutierrez R, Vega-Magana N, Pena-Rodriguez M, Zepeda-Nuno JS, Andrade-Marcial M, Campos-Uscanga Y, Jave-Suarez LF, Santos A, Cerda-Reyes E, Almeida-Lopez M, Martinez-Lopez E, Herrera LA, Armendariz-Borunda J. A Novel Foodstuff Mixture Improves the Gut-Liver Axis in MASLD Mice and the Gut Microbiota in Overweight/Obese Patients. Antioxidants (Basel). 2024 May 29;13(6):664. doi: 10.3390/antiox13060664.
- Rosas-Campos R, Meza-Rios A, Rodriguez-Sanabria JS, la Rosa-Bibiano R, Corona-Cervantes K, Garcia-Mena J, Santos A, Sandoval-Rodriguez A, Armendariz-Borunda J. Dietary supplementation with Mexican foods, Opuntia ficus indica, Theobroma cacao, and Acheta domesticus: Improving obesogenic and microbiota features in obese mice. Front Nutr. 2022 Dec 2;9:987222. doi: 10.3389/fnut.2022.987222. eCollection 2022.
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)
2025年2月26日
一次修了 (推定)
2026年10月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月14日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CI-06624
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?
はい
IPD プランの説明
All IPD underlying the results reported in publications derived from this study will be shared with investigators interesteted in this area, including demographic, clinical, biochemical, anthropometric, dietary, and microbiota-related data, after de-identification to protect participant confidentiality.
A data dictionary will also be provided to facilitate data interpretation.
IPD 共有時間枠
Starting 8 months after publication
IPD 共有アクセス基準
De-identified IPD will be made available to qualified researchers upon reasonable request.
Access will be granted for scientifically sound research purposes, including secondary analyses, meta-analyses, and validation studies.
Requests will be reviewed by the principal investigator and the research team based on the scientific merit of the proposal, the protection of participant confidentiality, and compliance with applicable regulations.
Data will be shared through a secure electronic transfer system after approval of a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。