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A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting

2026年11月9日 更新者:LOAM Science

A Randomized, Participant-Masked, Crossover Study Evaluating Postprandial Glycemic Response to Three Sweetener Preloads Consumed Before a Standardized Mixed Meal in Healthy Adults

This study is using a double-blind, randomize crossover evaluating the impact of three different sweeteners on postprandial glycemic response in a mixed meal setting. In 50 individuals, postprandial glucose response will be evaluated as a primary objective. Secondary objectives include additional measures of glucose response as well general gastrointestinal response to the sweeteners, assessed through a series of questionnaires.

調査の概要

状態

募集

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

研究場所

    • California
      • San Francisco、California、アメリカ、94109
        • 募集
        • Alethios
        • コンタクト:
          • Zeenia Framroze
          • 電話番号:650-206-8006

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Adults 18 or older
  • Body mass index between 18.5 and 29.9 kg/m2, inclusive, based on self-reported height and weight.
  • Self-reported general good health, without a diagnosis of diabetes or prediabetes.
  • Willing and able to consume the standardized study breakfast, consisting of a plain bagel with plain cream cheese, on six specified mornings.
  • Willing to wear a continuous glucose monitor continuously on the upper arm for approximately 10 consecutive days.
  • Willing to observe an overnight fast of at least 8 hours before each test morning and to follow test-day standardization instructions.
  • Owns a compatible smartphone with reliable internet access and is willing to install the required study and sensor applications.
  • Resides in the United States and is able to receive shipments at a residential address.
  • Able to read, understand, and communicate in English.
  • Willing and able to provide electronic informed consent through a digital platform.

Exclusion Criteria:

  • Diagnosis of type 1 diabetes, type 2 diabetes, prediabetes, or a history of gestational diabetes.
  • Current use of any glucose-lowering medication, including insulin, metformin, sulfonylureas, GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.
  • Current or recent use, within 30 days of consent, of systemic corticosteroids or any other medication known to materially alter glucose metabolism.
  • Celiac disease, wheat or gluten allergy or intolerance, or any dairy allergy or lactose intolerance that would preclude consumption of the standardized study breakfast or exclusion of gluten or dairy from the diet for any other reason that would preclude consumption of the standardized breakfast.
  • Known allergy or sensitivity to steviol glycosides, sucrose, or any declared component of the study preloads.
  • Known adhesive allergy or history of significant skin reaction to wearable sensors or medical adhesives.
  • Diagnosed gastrointestinal condition affecting digestion or absorption, including inflammatory bowel disease, gastroparesis, or prior bariatric or major gastrointestinal surgery.
  • Current eating disorder, or a diagnosed eating disorder within the previous 12 months.
  • Pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Regular night-shift work, or planned travel across more than two time zones during the study period.
  • Planned substantial change in diet, physical activity, or body weight during the study period.
  • Current alcohol use disorder or substance use disorder.
  • Participation in another interventional research study within 30 days of consent or concurrently with this study.
  • Any condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety or the integrity of the study data.

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:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • 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
実験的:Sequence 1

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

実験的:Sequence 2

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

実験的:Sequence 3

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

実験的:Sequence 4

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

実験的:Sequence 5

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

実験的:Sequence 6

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

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
Postprandial Area Under the Curve to 120 Minutes
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the preload consumption) through 120 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

二次結果の測定

結果測定
メジャーの説明
時間枠
Postprandial Area Under the Curve to 180 Minutes
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the preload consumption) through 180 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Postprandial Area Under the Curve to 120 Minutes Relative to Start of the Meal
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the meal consumption) through 120 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Peak Glucose
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Maximum observed glucose peak over the course of the 180 minute window.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Incremental Peak Glucose
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Maximum observed glucose peak relative to baseline over the course of the 180 minute window.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Time to Peak
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Elapsed time from preload consumption to the maximum observed value.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Post-Meal Subjective State
時間枠:Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Fullness, hunger, energy, and gastrointestinal comfort on a 0-10 numerical rating scale with 10 being an optimal situation and 0 representing the inverse for fullness, energy, and gastrointestinal comfort and 0 being an optimal situation and 10 representing the inverse for hunger. Questions are asked 60 and 180 minutes after the start of the mixed meal.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

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

協力者

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)

2026年11月9日

一次修了 (推定)

2027年1月15日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年10月19日

QC基準を満たした最初の提出物

2026年10月19日

最初の投稿 (実際)

2026年10月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • LOA003

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

IPD is proprietary information.

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。