Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time of Maximum Plasma Concentration (Tmax) of glycemia
研究概览
简要总结
To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.
详细描述
This is an interventional randomized, single blinded, cross over and controlled study.
The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.
The secondary objective is:
-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)
- Informed consent form
- Clinical examination
- Medical history
- Anthropometric characteristics
- Blood biochemical and hematological assessment
- Compliance test with the original matrix will be carried out
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Same flavor will be used for all matrices. The different matrices will be offered to volunteers in in individual packaged portions.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject
- •Subject over 65 years (included)
- •Subject over 61 kg (included)
- •Able to consume the 80g of fruit pastes in 10 minutes
- •Subject with a dentition consistent with the fruit paste consumption in 10 minutes
- •Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2
- •Subject agreeing to provide written consent
排除标准
- •Subject with acute pathology (unstable or terminal pathology, severe dementia)
- •Subject with renal failure (clearance < 60 ml/min)
- •Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)
- •Person with diabetes
- •Subject on food restriction
- •Subject undergoing chemotherapy
- •Subject with gastrointestinal pathology
- •Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)
研究组 & 干预措施
Original recipe
Normal fruit paste
干预措施: fruit paste matrice (Other)
maltodextrin recipe
fruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).
干预措施: fruit paste matrice (Other)
fructose recipe
fruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose
干预措施: fruit paste matrice (Other)
isomaltulose recipe
fruit pastes with some of the sugars will be replaced (25% min) by isomaltulose
干预措施: fruit paste matrice (Other)
mixed recipe
fruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose
干预措施: fruit paste matrice (Other)
结局指标
主要结局
Time of Maximum Plasma Concentration (Tmax) of glycemia
时间窗: day 28
Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Area Under the Curve (AUC) of glycemia
时间窗: day 28
Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Maximum Plasma Concentration (Cmax) of glycemia
时间窗: day 28
Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste
Area Under the Curve (AUC) of glycemia
时间窗: Day 0
Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Maximum Plasma Concentration (Cmax) of glycemia
时间窗: Day 0
Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Time of Maximum Plasma Concentration (Tmax) of glycemia
时间窗: Day 0
Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Area Under the Curve (AUC) of glycemia
时间窗: Day 7
Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Maximum Plasma Concentration (Cmax) of glycemia
时间窗: Day 7
Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Time of Maximum Plasma Concentration (Tmax) of glycemia
时间窗: day 7
Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Area Under the Curve (AUC) of glycemia
时间窗: day 14
Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Maximum Plasma Concentration (Cmax) of glycemia
时间窗: day 14
Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Time of Maximum Plasma Concentration (Tmax) of glycemia
时间窗: day 14
Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Area Under the Curve (AUC) of glycemia
时间窗: day 21
Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Maximum Plasma Concentration (Cmax) of glycemia
时间窗: day 21
Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
Time of Maximum Plasma Concentration (Tmax) of glycemia
时间窗: day 21
Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.
次要结局
- Maximum Plasma Concentration (Cmax) of urea(day 28)
- Time of Maximum Plasma Concentration (Tmax) of incretines(day 28)
- Area Under the Curve (AUC) of insulin(day 28)
- Area Under the Curve (AUC) of Grehlin(day 28)
- Maximum Plasma Concentration (Cmax) of fructose(Day 28)
- Time of Maximum Plasma Concentration (Tmax) of fructose(Day 28)
- Area Under the Curve (AUC) of leptin(day 28)
- Area Under the Curve (AUC) of fructose(Day 28)
- Maximum Plasma Concentration (Cmax) of glucagon(Day 28)
- Maximum Plasma Concentration (Cmax) of CCK(Day 28)
- Maximum Plasma Concentration (Cmax) of Grehlin(day 28)
- Area Under the Curve (AUC) of CCK(Day 28)
- Time of Maximum Plasma Concentration (Tmax) of CCK(Day 28)
- Maximum Plasma Concentration (Cmax) of leptin(day 28)
- Area Under the Curve (AUC) of glucagon(Day 28)
- Time of Maximum Plasma Concentration (Tmax) of glucagon(Day 28)
- Time of Maximum Plasma Concentration (Tmax) of Grehlin(day 28)
- Area Under the Curve (AUC) of GLP1(day 28)
- Area Under the Curve (AUC) of incretines(day 28)
- Time of Maximum Plasma Concentration (Tmax) of insulin(day 28)
- Questionnaire of satiety(at time 180 after ingestion in Day 28)
- Focus group(day 40)
- Maximum Plasma Concentration (Cmax) of incretines(day 28)
- Maximum Plasma Concentration (Cmax) of insulin(day 21)
- Area Under the Curve (AUC) of urea(day 28)
- Time of Maximum Plasma Concentration (Tmax) of urea(day 28)
- Facilited individual interview(day 40)
- Time of Maximum Plasma Concentration (Tmax) of leptin(day 28)
- Maximum Plasma Concentration (Cmax) of GLP1(day 28)
- Time of Maximum Plasma Concentration (Tmax) of GLP1(day 28)
- Questionnaire of acceptability(day 28)
- Area Under the Curve (AUC) of fructose(Day 0)
- Maximum Plasma Concentration (Cmax) of fructose(Day 0)
- Time of Maximum Plasma Concentration (Tmax) of fructose(Day 0)
- Area Under the Curve (AUC) of fructose(Day 7)
- Maximum Plasma Concentration (Cmax) of fructose(Day 7)
- Time of Maximum Plasma Concentration (Tmax) of fructose(Day 7)
- Area Under the Curve (AUC) of fructose(Day 14)
- Maximum Plasma Concentration (Cmax) of fructose(Day 14)
- Time of Maximum Plasma Concentration (Tmax) of fructose(Day 14)
- Area Under the Curve (AUC) of fructose(Day 21)
- Maximum Plasma Concentration (Cmax) of fructose(Day 21)
- Time of Maximum Plasma Concentration (Tmax) of fructose(Day 21)
- Area Under the Curve (AUC) of glucagon(day 0)
- Maximum Plasma Concentration (Cmax) of glucagon(day 0)
- Time of Maximum Plasma Concentration (Tmax) of glucagon(day 0)
- Area Under the Curve (AUC) of glucagon(day 7)
- Maximum Plasma Concentration (Cmax) of glucagon(day 7)
- Time of Maximum Plasma Concentration (Tmax) of glucagon(Day 7)
- Area Under the Curve (AUC) of glucagon(Day 14)
- Maximum Plasma Concentration (Cmax) of glucagon(Day 14)
- Time of Maximum Plasma Concentration (Tmax) of glucagon(Day 14)
- Area Under the Curve (AUC) of glucagon(Day 21)
- Maximum Plasma Concentration (Cmax) of glucagon(Day 21)
- Time of Maximum Plasma Concentration (Tmax) of glucagon(Day 21)
- Area Under the Curve (AUC) of CCK(Day 0)
- Maximum Plasma Concentration (Cmax) of CCK(Day 0)
- Time of Maximum Plasma Concentration (Tmax) of CCK(Day 0)
- Area Under the Curve (AUC) of CCK(Day 7)
- Maximum Plasma Concentration (Cmax) of CCK(Day 7)
- Time of Maximum Plasma Concentration (Tmax) of CCK(Day 7)
- Area Under the Curve (AUC) of CCK(Day 14)
- Maximum Plasma Concentration (Cmax) of CCK(Day 14)
- Time of Maximum Plasma Concentration (Tmax) of CCK(Day 14)
- Area Under the Curve (AUC) of CCK(Day 21)
- Maximum Plasma Concentration (Cmax) of CCK(Day 21)
- Time of Maximum Plasma Concentration (Tmax) of CCK(Day 21)
- Area Under the Curve (AUC) of Grehlin(Day 0)
- Maximum Plasma Concentration (Cmax) of Grehlin(Day 0)
- Time of Maximum Plasma Concentration (Tmax) of Grehlin(day 0)
- Area Under the Curve (AUC) of Grehlin(day 7)
- Maximum Plasma Concentration (Cmax) of Grehlin(day 7)
- Time of Maximum Plasma Concentration (Tmax) of Grehlin(day 7)
- Area Under the Curve (AUC) of Grehlin(day 14)
- Maximum Plasma Concentration (Cmax) of Grehlin(day 14)
- Time of Maximum Plasma Concentration (Tmax) of Grehlin(day 14)
- Area Under the Curve (AUC) of Grehlin(day 21)
- Maximum Plasma Concentration (Cmax) of Grehlin(day 21)
- Time of Maximum Plasma Concentration (Tmax) of Grehlin(day 21)
- Area Under the Curve (AUC) of leptin(day 0)
- Maximum Plasma Concentration (Cmax) of leptin(day 0)
- Time of Maximum Plasma Concentration (Tmax) of leptin(day 0)
- Area Under the Curve (AUC) of leptin(day 7)
- Maximum Plasma Concentration (Cmax) of leptin(day 7)
- Time of Maximum Plasma Concentration (Tmax) of leptin(day 7)
- Area Under the Curve (AUC) of leptin(day 14)
- Maximum Plasma Concentration (Cmax) of leptin(day 14)
- Time of Maximum Plasma Concentration (Tmax) of leptin(day 14)
- Area Under the Curve (AUC) of leptin(day 21)
- Maximum Plasma Concentration (Cmax) of leptin(day 21)
- Time of Maximum Plasma Concentration (Tmax) of leptin(day 21)
- Area Under the Curve (AUC) of GLP1(day 0)
- Maximum Plasma Concentration (Cmax) of GLP1(day 0)
- Time of Maximum Plasma Concentration (Tmax) of GLP1(day 0)
- Area Under the Curve (AUC) of GLP1(day 7)
- Maximum Plasma Concentration (Cmax) of GLP1(day 7)
- Time of Maximum Plasma Concentration (Tmax) of GLP1(day 7)
- Area Under the Curve (AUC) of GLP1(day 14)
- Maximum Plasma Concentration (Cmax) of GLP1(day 14)
- Time of Maximum Plasma Concentration (Tmax) of GLP1(day 14)
- Area Under the Curve (AUC) of GLP1(day 21)
- Maximum Plasma Concentration (Cmax) of GLP1(day 21)
- Time of Maximum Plasma Concentration (Tmax) of GLP1(day 21)
- Area Under the Curve (AUC) of incretines(day 0)
- Maximum Plasma Concentration (Cmax) of incretines(day 0)
- Time of Maximum Plasma Concentration (Tmax) of incretines(day 0)
- Area Under the Curve (AUC) of incretines(day 7)
- Maximum Plasma Concentration (Cmax) of incretines(day 7)
- Time of Maximum Plasma Concentration (Tmax) of incretines(day 7)
- Area Under the Curve (AUC) of incretines(day 14)
- Maximum Plasma Concentration (Cmax) of incretines(day 14)
- Time of Maximum Plasma Concentration (Tmax) of incretines(day 14)
- Area Under the Curve (AUC) of incretines(day 21)
- Maximum Plasma Concentration (Cmax) of incretines(day 21)
- Time of Maximum Plasma Concentration (Tmax) of incretines(day 21)
- Area Under the Curve (AUC) of insulin(day 0)
- Maximum Plasma Concentration (Cmax) of insulin(day 0)
- Time of Maximum Plasma Concentration (Tmax) of insulin(day 0)
- Area Under the Curve (AUC) of insulin(day 7)
- Maximum Plasma Concentration (Cmax) of insulin(day 7)
- Time of Maximum Plasma Concentration (Tmax) of insulin(day 7)
- Area Under the Curve (AUC) of insulin(day 14)
- Maximum Plasma Concentration (Cmax) of insulin(day 14)
- Time of Maximum Plasma Concentration (Tmax) of insulin(day 14)
- Area Under the Curve (AUC) of insulin(day 21)
- Time of Maximum Plasma Concentration (Tmax) of insulin(day 21)
- Area Under the Curve (AUC) of urea(day 0)
- Maximum Plasma Concentration (Cmax) of urea(day 0)
- Time of Maximum Plasma Concentration (Tmax) of urea(day 0)
- Area Under the Curve (AUC) of urea(day 7)
- Maximum Plasma Concentration (Cmax) of urea(day 7)
- Time of Maximum Plasma Concentration (Tmax) of urea(day 7)
- Area Under the Curve (AUC) of urea(day 14)
- Maximum Plasma Concentration (Cmax) of urea(day 14)
- Time of Maximum Plasma Concentration (Tmax) of urea(day 14)
- Area Under the Curve (AUC) of urea(day 21)
- Maximum Plasma Concentration (Cmax) of urea(day 21)
- Time of Maximum Plasma Concentration (Tmax) of urea(day 21)
- Questionnaire of satiety(at time 0 after ingestion in Day 0)
- Questionnaire of satiety(at time 60 after ingestion in Day 0)
- Questionnaire of satiety(at time 180 after ingestion in Day 0)
- Questionnaire of satiety(at time 0 after ingestion in Day 7)
- Questionnaire of satiety(at time 60 after ingestion in Day 7)
- Questionnaire of satiety(at time 180 after ingestion in Day 7)
- Questionnaire of satiety(at time 0 after ingestion in Day 14)
- Questionnaire of satiety(at time 60 after ingestion in Day 14)
- Questionnaire of satiety(at time 180 after ingestion in Day 14)
- Questionnaire of satiety(at time 0 after ingestion in Day 21)
- Questionnaire of satiety(at time 60 after ingestion in Day 21)
- Questionnaire of satiety(at time 180 after ingestion in Day 21)
- Questionnaire of satiety(at time 0 after ingestion in Day 28)
- Questionnaire of satiety(at time 60 after ingestion in Day 28)
- Questionnaire of acceptability(day 0)
- Questionnaire of acceptability(day 7)
- Questionnaire of acceptability(day 14)
- Questionnaire of acceptability(day 21)