SucroMet Nutritional Intervention Trial
SucroMet' Nutritional Intervention: Study of the Metabolic Impact of Sucrose (Natural Sugar) and Sucralose (Artificial Sweetener) Intake at Different Doses and Modes of Consumption in Adults With Normal Weight, Overweight, and Obesity
SucroMet is designed to evaluate how adding two commonly used sweeteners-sucrose (table sugar) and sucralose (a low-calorie sweetener)-at low and high doses may influence glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity.
The low-dose intervention consists of 5% of the Estimated Energy Requirement (EER) from sucrose or 5 sucralose tablets per day (approximately 33.35 mg/day of sucralose). The high-dose intervention consists of 10% of EER from sucrose or 10 sucralose tablets per day (approximately 66.7 mg/day of sucralose). These doses maintain the planned 1:2 exposure ratio between the low- and high-dose intervention groups.
Before the intervention begins, participants' habitual dietary intake is assessed and, when necessary, minor dietary adjustments are made to support a stable overall eating pattern while maintaining energy intake. Participants then complete a four-week run-in period during which these recommendations are followed, and dietary records are used to verify dietary stability before the intervention starts.
Participants will consume the assigned sweetener incorporated into foods or beverages that they already consume as part of their habitual diet, without substantial changes to their usual eating patterns. The intervention includes two consecutive 12-week phases, one involving solid food intake and the other involving liquid intake, separated by a two-week washout period. This design allows evaluation of the effects of sweetener type, dose, and mode of consumption.
The primary outcomes are changes in glucose regulation, including fasting plasma glucose and insulin resistance assessed by HOMA-IR. Secondary outcomes include changes in body composition, anthropometric measurements, blood pressure, routine biochemical parameters, gut microbiota composition, DNA methylation patterns in peripheral blood cells, and biomarkers related to inflammation, oxidative stress, and metabolomic profiles measured in blood and urine.
Participants will attend scheduled study visits for anthropometric assessments, dietary evaluations, and biological sample collection. Blood, urine, and stool samples will be obtained at baseline and after each intervention phase.
The study aims to address the following questions:
- Do metabolic responses to sucrose and sucralose, including changes in insulin resistance (HOMA-IR) and fasting plasma glucose, differ according to participants' body mass index (BMI)?
- Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health?
- Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition?
- Are changes in DNA methylation patterns in peripheral blood cells associated with the consumption of sucrose and sucralose at different doses and in different forms?
- Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?
調査の概要
状態
詳細な説明
SucroMet is a randomized controlled nutritional intervention designed to investigate the metabolic effects of sucrose and sucralose consumption under conditions that closely reflect habitual dietary practices. The study aims to determine whether sweetener type, dose, and mode of consumption influence glucose regulation and related biological pathways in adults with normal weight, overweight, or obesity. The study evaluates the independent and combined effects of sweetener type, dose, and mode of consumption. By maintaining overall dietary habits and energy intake as stable as possible throughout the intervention, the design aims to isolate the specific contribution of sweetener exposure to observed metabolic changes.
A distinctive feature of the study is the comparison of sweeteners administered in both solid and liquid forms, allowing assessment of whether the food matrix modifies physiological responses. The study also examines whether responses differ according to adiposity status, enabling exploration of potential interactions between sweetener exposure and body mass index.
Beyond glucose regulation, the study investigates several biological pathways that may contribute to individual variability in response to sweetener intake, including gut microbiota composition, epigenetic regulation, inflammation, oxidative stress, and systemic metabolic profiles. The integration of clinical, biochemical, molecular, and metabolomic data is intended to provide a comprehensive characterization of the biological effects associated with long-term sweetener consumption.
The results are expected to improve understanding of the metabolic consequences of sucrose and sucralose intake and to contribute evidence relevant to future nutritional recommendations and public health strategies.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Libia Alejandra Garcìa Flores, PhD.
- 電話番号：(+34) 951 440 260
- メール：libia.garcia@ibima.eu
研究連絡先のバックアップ
- 名前：José Manuel García Almeida, MD, PhD.
- 電話番号：(+34) 951032244
- メール：jgarciaalmeida@uma.es
研究場所
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Malaga
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Málaga、Malaga、スペイン、29103
- 募集
- Hospital Universitario Virgen de la Victoria
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コンタクト：
- Libia Alejandra García Flores, PhD.
- 電話番号：0034636938538
- メール：libia.garcia@ibima.eu
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コンタクト：
- Lourdes Garrido Sánchez, PhD.
- 電話番号：0034629910317
- メール：lourgarrido@gmail.com
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参加基準
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
説明
Inclusion Criteria:
- Adults aged 18 to 65 years at the time of enrollment.
- Body Mass Index (BMI) between 18.5 and 39.9 kg/m².
- Men and women who report a preference for sweet taste and habitual consumption of sugar and/or sweeteners.
Individuals in good general health, as determined by:
- Medical history and clinical evaluation;
- Absence of uncontrolled chronic diseases, such as diabetes, metabolic syndrome, severe hypertension, or advanced liver or renal disease; and
- Baseline biochemical parameters within normal reference ranges, including fasting plasma glucose <100 mg/dL, HbA1c <5.7%, normal liver and renal function (ALT/AST and creatinine within reference ranges), and blood pressure <140/90 mmHg without pharmacological treatment.
- Less than 4 hours per week of moderate-to-vigorous physical activity.
- Not following special or restrictive diets (e.g., ketogenic, strict vegetarian, or vegan diets).
- Not taking medications known to affect metabolism, including, for example, antidiabetic drugs, systemic corticosteroids, weight-loss medications, or high-dose antioxidant supplements, except for stable use of hormonal contraceptives.
- Willingness to maintain habitual diet and physical activity throughout the study, with the only modification being the assigned sweetener intervention.
- Ability and willingness to comply with all study procedures and scheduled visits.
- Provision of written informed consent before participation.
Exclusion Criteria:
- Gastrointestinal disorders influencing digestion or nutrient absorption (e.g., inflammatory bowel disease, celiac disease, malabsorption syndromes).
- History of cancer not in remission.
- Uncontrolled thyroid disorders.
- History of bariatric surgery or extreme weight loss within the past 12 months.
- Pregnancy, breastfeeding, or planning pregnancy during the study period.
- Acute illness, major infection, hospitalization, or major surgery within the previous 6 months.
- Any condition that, in the investigators' judgment, could compromise participant safety, protocol adherence, or interpretation of the study results.
研究計画
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：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 |
|---|---|
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実験的：Sucrose - Low Dose
Participants assigned to this arm will consume sucrose at a low dose equivalent to five percent of their individual estimated energy requirement.
The sucrose will be incorporated into foods or beverages that are part of the habitual diet, while total daily calorie intake is maintained.
Participants will complete two intervention phases, including solid and liquid intake forms, according to the crossover design.
|
Sucralose tablets administered at a total dose of approximately 33.35 mg/day (5 tablets/day).
Tablets are consumed daily and distributed across meals.
Participants receive the assigned dose throughout both intervention periods and consume the sweetener in both solid and liquid forms according to the study crossover schedule.
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|
実験的：Sucrose - High Dose
Participants assigned to this arm will consume sucrose at a high dose equivalent to ten percent of their individual estimated energy requirement.
The sucrose will be incorporated into foods or beverages that are part of the habitual diet, while total daily calorie intake is maintained.
Participants will complete two intervention phases, including solid and liquid intake forms, according to the crossover design.
|
Sucrose administered at a dose equivalent to 10% of the participant's estimated daily energy requirement.
The required amount is individually calculated and provided in pre-weighed sachets for daily consumption.
Participants consume the assigned dose in foods or beverages during both intervention periods according to the crossover schedule.
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実験的：Sucralose - Low Dose
Participants assigned to this arm will consume a low dose of sucralose (approximately 33.35 mg/day), administered as five sucralose tablets per day and distributed across regular meals.
The sucralose will be incorporated into foods or beverages consumed as part of the habitual diet while maintaining stable total daily energy intake.
Participants will complete both solid and liquid intake intervention phases according to the crossover design.
|
Sucrose administered at a dose equivalent to 5% of the participant's estimated daily energy requirement.
The required amount is individually calculated and provided in pre-weighed sachets for daily consumption.
Participants consume the assigned dose in foods or beverages during both intervention periods according to the crossover schedule.
|
|
実験的：Sucralose - High Dose
Participants assigned to this arm will consume a high dose of sucralose (approximately 66.7 mg/day), administered as ten sucralose tablets per day and distributed across regular meals.
The sucralose will be incorporated into foods or beverages consumed as part of the habitual diet while maintaining stable total daily energy intake.
Participants will complete both solid and liquid intake intervention phases according to the crossover design.
|
Sucralose tablets administered at a total dose of approximately 66.7 mg/day (10 tablets/day).
Tablets are consumed daily and distributed across meals.
Participants receive the assigned dose throughout both intervention periods and consume the sweetener in both solid and liquid forms according to the study crossover schedule.
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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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Change in HOMA-IR Index
時間枠：Baseline (before intervention) and End of each 12-week intervention phase
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Insulin resistance will be assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).
Results will be reported as HOMA-IR values.
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Baseline (before intervention) and End of each 12-week intervention phase
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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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Glycemic biomarker
時間枠：Baseline and End of each 12-week intervention phase
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Change in Hemoglobin A1c (%): Hemoglobin A1c measured as an indicator of long-term glycemic control.
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Baseline and End of each 12-week intervention phase
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Change in Fat Mass
時間枠：Baseline and End of each 12-week intervention phase
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Fat mass (kg) is assessed using bioelectrical impedance analysis (BIA).
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Baseline and End of each 12-week intervention phase
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Change in Systolic Blood Pressure
時間枠：Baseline and End of each 12-week intervention phase
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Systolic blood pressure is measured under standardized clinical conditions using validated devices.
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Baseline and End of each 12-week intervention phase
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Change in Triglycerides
時間枠：Baseline and End of each 12-week intervention phase
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Triglyceride levels (mg/dL) are measured using standard clinical laboratory methods.
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Baseline and End of each 12-week intervention phase
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Change in Relative Abundance of Gut Microbiota
時間枠：Baseline and End of each 12-week intervention phase
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Gut microbiota composition is assessed in stool samples using 16S rRNA gene sequencing by quantifying the relative abundance of bacterial taxa at different taxonomic levels.
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Baseline and End of each 12-week intervention phase
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Change in DNA Methylation in Peripheral Blood Mononuclear Cells
時間枠：Baseline and End of each 12-week intervention phase
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DNA methylation levels are assessed in peripheral blood mononuclear cells (PBMCs) by quantifying methylation at specific CpG sites using bisulfite-based epigenetic analysis techniques.
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Baseline and End of each 12-week intervention phase
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Change in Urinary Oxylipin Levels
時間枠：Baseline and End of each 12-week intervention phase
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Urinary oxylipin levels, including isoprostanes, prostaglandins, and thromboxanes, are quantified in first-morning urine samples using targeted mass spectrometry and normalized to urinary creatinine.
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Baseline and End of each 12-week intervention phase
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協力者と研究者
捜査官
- 主任研究者：Libia Alejandra García Flores, PhD、Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
- 主任研究者：José Manuel García Almeida, MD, PhD.、Andaluz Health Service
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- SucroMet
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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