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Danish Pulses Meal Study (Danish Pulses)

2026年5月1日 更新者：University College Absalon

Danish Pulses: Tasty, Healthy, and Safe Danish Pulses With Added Value for The Users

The goal of this clinical trial is to learn whether daily intake of lactic acid bacteria fermented or unfermented legumes can improve metabolic and gut health in healthy adults.

The main questions it aims to answer are:

  • Does eating 100 g per day of legumes for 2 weeks lower blood glucose, measured primarily by continuous glucose monitoring, compared with a control period of habitual diet?
  • Does eating 100 g per day of legumes for 2 weeks improve inflammation, cholesterol, gut microbiome composition, and short-chain fatty acid (SCFA) levels, and do fermented legumes have additional effects on body composition compared with unfermented legumes? Researchers will compare participants consuming LAB-fermented legumes with participants consuming unfermented legumes to see if fermented legumes produce greater health benefits, particularly for body composition and other metabolic outcomes.

Participants will:

  • Follow their habitual diet for 14 days during a control period.
  • Complete baseline measurements after the control period.
  • Be randomly assigned to consume 100 g per day of either LAB-fermented or unfermented legumes for 14 days.
  • Eat the provided standardized legume foods as part of their usual meals.
  • Undergo continuous glucose monitoring and other assessments, incl. inflammation, cholesterol, long-term blood glucose, blood pressure, body composition, fecal microbiome, dietary intake, and digestive symptoms.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

50

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

  • 名前：Tenna Mie Christoffersen, ph.D
  • 電話番号：+45 72482246
  • メール：tch@pha.dk

研究連絡先のバックアップ

  • 名前：Louise Almer, phD student
  • 電話番号：+45 72482258
  • メール：loua@pha.dk

研究場所

  • デンマーク
      • Slagelse、デンマーク、4200
        • University College Absalon
        • コンタクト：
          • Kim Daugaard
          • 電話番号：+45 72 482229
          • メール：kimd@pha.dk
        • コンタクト：
          • Martin Smedegaard Vinvig
          • 電話番号：+45 72482261
          • メール：mavi@pha.dk
        • 主任研究者：
          • Tenna Christoffersen, PhD
        • 副調査官：
          • Louise Almer, PhD student

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

はい

説明

Inclusion Criteria:

  • No diabetes

Exclusion Criteria:

  • Treatment with antibiotics within the last three months.
  • Ongoing treatment with non-steroidal anti-inflammatory drugs.
  • Metabolic diseases, including diabetes.
  • Inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis.
  • Allergies or intolerance to legumes.
  • People that report eating > 25 g per day of legumes as part of their habitual diet.

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：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Fermented pulses group 1
Participants will be instructed to consume 100 g of lactic acid fermented pulses daily as part of their usual diet.
ダイエットサプリメント：Pulses meal study
The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of lactic acid fermented pulses every day, seven days a week, for two weeks. Fermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume flour, adding up to 100 g of legumes per day. These test foods can be eaten throughout the day; however, intake of other legumes, except those included in the foods, should be avoided.
実験的：Unfermented pulses group 2
Participants will be instructed to consume 100 g of unfermented pulses daily as part of their usual diet.
ダイエットサプリメント：Pulses Meal Study
The participants are randomly assigned to two experimental groups based on a randomized trial design: two weeks of habitual dietary intake (control period) followed by the second intervention period lasts from day 14 to day 28, during which participants will be instructed to consume 100 g of unfermented pulses every day, seven days a week, for two weeks. The unfermented pulses will be provided and packed as standardized food items to their habitual meals e.g. as hummus, or pasta with legume flour, adding up to 100 g of legumes per day. These test foods can be eaten throughout the day; however, intake of other legumes, except those included in the foods, should be avoided.

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
Continuous glucose monitoring
時間枠：From day zero to 14 days and from day 14 to day 28
Continuous Glucose Monitoring (CGM) will be measured in real-time and intermittently scanned CGM (isCGM) bi-weekly with an isCGM sensor (model Abbott Freestyle Libre PRO). This method is a minimally invasive method, as the sensor is placed on the participant's arm (26-30), by participants themselves after careful instructions, incl. videos. The Abbott Freestyle Libre PRO is blinded to the participants to avoid habitual changes, and it measures CGM in real-time throughout the entire 14-day period. The study follows the Standardized CGM metrics for Clinical Care, and the 14-day duration is aligned with the international recommendations (26,30). To ensure accurate and meaningful interpretation of CGM, adequate glucose data is collected according to the recommendation (70% of data from 14 days) (26,30). Data from participants with a CGM activity < 70% will be analyzed with the intention to treat principles.
From day zero to 14 days and from day 14 to day 28

二次結果の測定

結果測定
メジャーの説明
時間枠
Inflammation CRP level
時間枠：Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting C-reactive proteins (CRP) monitoring will be measured at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting Cholesterol
時間枠：Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting cholesterol monitoring will be conducted at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Long-term blood glucose
時間枠：Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Fasting hemoglobin A1c (HbA1c) monitoring will be conducted at baseline, 14 days, and at day 28 by a finger prick test using a QuickRead go PLUS Instrument (#154580-4).
Three measures; at baseline (day 0), follow up 1(day 14) and at follow up 2 (day 28).
Blood pressure
時間枠：Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Systolic and diastolic blood pressures will be measured at baseline, day 14, and at day 28. Blood pressures will be measured in millimeters of mercury using an automatic blood pressure monitor (Digital Automatic Blood Pressure Monitor, Omron). Participants will be asked to lie down and relax for approximately 8 to 10 minutes, and 3 blood pressure measurements will be recorded at 5-minute intervals.
Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Body composition
時間枠：Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).

Anthropometric measurements, will be measured by a Body Impedance Analytics (BIA) (TANITA MC 780 MA S, Japan).

Height (m) will be measured using a standard dynamometer without shoes and is recorded to the nearest 0.1 cm.

Body mass index (BMI) is calculated by dividing weight (kg) by height (m) squared (kg/m2).

Waist and hip circumferences will be measured using a standardized tape measure that is calibrated before use. Waist circumference (cm) will be measured at the midpoint between the lowest rib and the upper part of the iliac bone in a standing position. Hip circumference (cm) will be measured at the site of the largest circumference between the waist and thighs.
Three measurements; at baseline (day 0), follow up 1 (day 14) and at follow up 2 (day 28).
Fecal sample
時間枠：Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).
Fecal samples (approximately 10 g) will be collected from all participants. Participants are collecting the samples by themselves using the EasySampler tool kit, including a thorough written introduction(33,34). Fecal pH will be determined by mixing fecal matter 1:2 with sterile MilliQ-water after which pH is measured. Total fecal DNA will be extracted using standard methods. The gut microbial metagenome will be determined by shotgun high-throughput sequencing using long-read Oxford Nanopore-based sequencing. Before any further bioinformatics processing the raw reads will be purged of any human DNA-related sequences.. Fecal short chain fatty acids and other fecal metabolite concentrations, incl. free amino acids, are determined using high-field nuclear magnetic resonance NMR on fecal samples.
Three measurements: at baseline (day 0), follow up 1 (day 14), and at follow up 2 (day 28).
Dietary intake
時間枠：Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).

Data on dietary intake will be collected by three-day dietary records with photos to evaluate adherence to the intervention. The dietary records will be collected once during the control period and once during the intervention period. Photos will be used for main meals and leftovers of legumes.

Physical activity will also be documented as part of the dietary records and used to estimate energy expenditure. Furthermore, data on dietary intake will be used to assess compliance with the intervention.
Three measurements: at baseline (day 0), follow-up 1 (day 14) and follow-ip 2 (day 28).
Digestive abnormalities
時間枠：Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).
Digestive abnormalities are identified through IBS symptoms and will be assessed using self-reported questionnaires using the IBS Severity Scoring System (IBS-SSS) for assessment of the following symptoms: abdominal distension, abdominal pain, satisfaction with bowel habits, and the extent to which symptoms affect the quality of life (QoL).
Three measurements: at baseline (day 0) , follow-up 1 (day 14), and at follow-up 2 (day 28).

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 College Absalon

捜査官

  • スタディディレクター：Margit Dall Aaslyng, PhD、University College Absalon

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 (推定)

2026年9月10日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年5月1日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月7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1日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • SJ-1132-120770
  • 34009-23-2191 (その他の助成金/資金番号：Green Development and Demonstration Programme (GUDP))

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?

いいえ

IPD プランの説明

Data are person-centered and ethical commitee requires no sharing.

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

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