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临床试验/NCT06994403
NCT06994403招募中不适用

Evaluation of the Glycemic Response to a Pasta Enriched With Carob Flour: a Study Conducted in Healthy Subjects and a Study Conducted in Subjects With Type 1 Diabetes Mellitus

Federico II University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Glycemic Index of Carob-Enriched Durum Wheat Pasta

研究概览

简要总结

Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages. Its pulp, once the seeds are removed, is milled into carob flour, a nutrient-rich food containing fiber, carbohydrates, proteins, and essential minerals such as potassium, magnesium, sodium, phosphorus, and calcium. Carob flour is also naturally sweet and can serve as a cocoa powder substitute in desserts. Furthermore, it is a source of polyphenols with known antioxidant properties.

Clinical evidence suggests that consumption of foods rich in refined carbohydrates is associated with elevated postprandial blood glucose levels, which are recognized as an independent cardiovascular risk factor. The glycemic index (GI) is a useful parameter to assess the impact of carbohydrate-containing foods on postprandial glycemic response. Based on carbohydrate quality, foods are classified as having high, medium, or low GI. Consumption of high-GI foods leads to a stronger glycemic response and has been linked to increased risk of chronic conditions such as type 2 diabetes, obesity, and cardiovascular disease.

Given its bromatological profile, carob flour may have the potential to modulate postprandial glycemic responses. However, studies evaluating the GI of carob-based products have shown inconsistent findings. In one randomized trial involving 10 healthy adults, a carob-based snack demonstrated a lower GI (40) compared to a chocolate cookie with an equivalent carbohydrate content (GI 78), using glucose as the reference. The same study found that consuming the carob snack before a meal led to a reduced postprandial glycemic response, decreased hunger, and lower caloric intake at an ad libitum meal. Another study on 7 healthy individuals reported a GI of 39 for carob flour bars containing 26 g of available carbohydrates. Conversely, a study involving 20 healthy participants found that consuming 5 or 10 g of carob pulp with 200 mL of water and 50 g glucose increased postprandial glycemic and insulinemic responses compared to water and glucose alone. This effect was not observed with a 20 g dose of carob pulp.

Among carbohydrate-rich foods, pasta represents a key component of the Italian diet and, due to its physical structure, generally has a low-to-moderate GI. Compared to other wheat-based foods like bread, pasta tends to produce a lower postprandial glycemic response when carbohydrate content is matched. However, the impact of adding carob flour to durum wheat semolina in pasta production on postprandial glycemia remains unexplored.

The current research project consists of two studies. The first study aims to determine the glycemic index of carob-enriched durum wheat pasta in healthy adult volunteers, using white bread as the reference food. The second study investigates the postprandial glycemic response to the same carob-enriched pasta in individuals with type 1 diabetes, comparing it to traditional durum wheat pasta. These studies are designed to contribute to the understanding of carob flour's role in glycemic control, with potential implications for dietary management in both healthy individuals and patients with diabetes.

详细描述

Study 1:

This randomized, controlled, crossover trial aims to determine the glycemic index (GI) of a durum wheat pasta enriched with carob flour in healthy adult males. Over a period of three months, participants will consume test meals on separate days under controlled conditions. The glycemic response will be compared to that elicited by white bread, which serves as the reference food. This study is conducted in an outpatient setting and will contribute to the evaluation of the metabolic impact of carob-enriched pasta on postprandial glycemia.

Study 2:

This controlled, crossover study is designed to assess the postprandial glycemic response to carob flour-enriched pasta in individuals with type 1 diabetes using continuous glucose monitoring (CGM). Conducted over a 12-month period, the study involves alternating consumption of carob-enriched and standard durum wheat pasta. Participants will follow their usual dietary habits while maintaining consistent meal composition and daily routines during the test days. The study aims to explore the potential of carob-enriched pasta to modulate postprandial glycemia in a population with impaired glucose regulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy male volunteers
  • •Age between 18 and 50 years
  • •Body Mass Index (BMI) between 18 and 29 kg/m²
  • •Male and female individuals
  • •Age ≥ 18 years
  • •Confirmed diagnosis of type 1 diabetes mellitus
  • •Use of a continuous glucose monitoring (CGM) system

排除标准

  • •Diagnosis of diabetes mellitus
  • •Presence of any chronic-degenerative disease
  • •Any acute or chronic medical condition that could seriously compromise overall health
  • •Diagnosis of celiac disease
  • •Presence of serious chronic illnesses (e.g., coronary heart disease, renal failure, liver diseases, endocrine disorders)
  • •Gastrointestinal disorders
  • •Pregnancy or breastfeeding
  • •Alcohol or drug dependence

研究组 & 干预措施

Carob-Enriched Durum Wheat Pasta

Experimental

Participants will consume 68 g of carob-enriched durum wheat pasta (231 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Durum wheat pasta enriched with carob flour (Dietary Supplement)

Carob-Enriched Durum Wheat Pasta

Experimental

Participants will consume 68 g of carob-enriched durum wheat pasta (231 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Standard durum wheat pasta (Dietary Supplement)

Carob-Enriched Durum Wheat Pasta

Experimental

Participants will consume 68 g of carob-enriched durum wheat pasta (231 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: White bread reference meal (Dietary Supplement)

Durum Wheat Pasta

Sham Comparator

Participants will consume 63 g of traditional durum wheat pasta (221 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Durum wheat pasta enriched with carob flour (Dietary Supplement)

Durum Wheat Pasta

Sham Comparator

Participants will consume 63 g of traditional durum wheat pasta (221 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Standard durum wheat pasta (Dietary Supplement)

Durum Wheat Pasta

Sham Comparator

Participants will consume 63 g of traditional durum wheat pasta (221 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: White bread reference meal (Dietary Supplement)

White Bread (Reference Food)

Active Comparator

Participants will consume 84 g of white bread (225 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Durum wheat pasta enriched with carob flour (Dietary Supplement)

White Bread (Reference Food)

Active Comparator

Participants will consume 84 g of white bread (225 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: Standard durum wheat pasta (Dietary Supplement)

White Bread (Reference Food)

Active Comparator

Participants will consume 84 g of white bread (225 kcal) containing 50 g of available carbohydrates, served with 55 g of tomato sauce prepared with 2.5 g of extra virgin olive oil.

干预措施: White bread reference meal (Dietary Supplement)

结局指标

主要结局

Glycemic Index of Carob-Enriched Durum Wheat Pasta

时间窗: Within 2 hours after consumption of the test meal on three separate test days (each separated by at least 2 days).

The primary outcome is the determination of the glycemic index (GI) of a carob-enriched durum wheat pasta compared to white bread, used as the reference food. The glycemic response will be assessed through blood glucose concentrations measured at fasting and at 15, 30, 60, 90, and 120 minutes after consumption.

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lutgarda Bozzetto

Professor

Federico II University

研究点 (1)

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