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临床试验/NCT05774119
NCT05774119已完成不适用

Effect of Coffee Consumption on Hunger, Satiety, and Appetite-regulating Hormones in Women With Overweight or Obesity

University of Guadalajara2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Change in dietary intake

研究概览

简要总结

The effect of coffee consumption on appetite is not clear, there are studies that show an effect on the regulation of energy intake, reducing hunger and/or increasing satiety. The purpose of this trial is to evaluate the effect of 6 mg/caffeine/kg of body weight on hunger, satiety, dietary intake, biochemical variables and ghrelin and cholecystokinin concentration in overweight and obese women.

详细描述

Randomized crossover clinical trial to be realized in women between 20 and 40 years of age with overweight or obesity and apparently healthy who reside in the city of Guadalajara, Jalisco.

Their participation involves their attendance to 3 interventions, in the first one it is verified whether or not they meet the inclusion criteria, a clinical history is applied to take information on pathological history, clinical data, nutritional aspects, sociodemographic and lifestyle aspects and anthropometric measurements; then they are randomly assigned to the two types of interventions in the next two subsequent ones.

In the second and third interventions (with an interval of 7 days between them), participants will attend in the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite.

They will arrive at the institute at 8 am after an overnight fast, consume a standard 400 kcal breakfast with a distribution of 55% carbohydrates, 30% lipids and 15% protein. along with 240 ml of coffee with 6 mg/caffeine/kg body weight or the same breakfast, but with 240 ml of water.

On an empty stomach and every 30 min during the 3 h following the consumption of breakfast with the beverage, the participants recorded their level of hunger, fullness, satiety, desire to eat and prospective consumption, desire to eat specific foods: sweet, salty, fatty, tasty, and sed through visual analog scales (VAS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 20 and 40 years old
  • Body mass index between 25-40 kg/m
  • Regular menstrual cycle of 23-32 days in the last 3 months.
  • Moderate consumption of coffee (up to 4 cups per day)
  • Having the habit of eating breakfast
  • Availability of time in the morning

排除标准

  • Use of any type of contraceptives in the last three months.
  • Use of hypoglycemic, lipid-lowering, weight-loss, appetite altering and psychiatric medications.
  • Diagnosis of diabetes mellitus, hypertension, cancer, polycystic ovary syndrome, hypothyroidism, hyperthyroidism, infectious disease, renal disease, dysgeusia, and gallbladder disease.
  • Weight loss ≥5% of their weight in the last 6 months.
  • Consumption of more than 20 g of alcohol per day.
  • Pregnant or breastfeeding
  • vegetarian or vegan

结局指标

主要结局

Change in dietary intake

时间窗: Post intervention, the following 24 hours after finishing the intervention

Analysis of the 24 hour dietary intake recall consumed the rest of the day after the intervention. Analyzed with the Nutritionist Pro TM Software.

Change in cholecystokinin concentration

时间窗: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.

Cholecystokinin measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is Human CCK Enzyme Immunoassay Kit catalog number EIA-CCK-1. Cholecystokinin is measured in pg/mL.

Change in appetite feelings

时间窗: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.

Hunger, fullness, satiety, desire to eat and prospective consumption are assessed with the visual analog scales (VAS). They are composed of 100 mm long lines, where at one end the term "None" or "Not at all" is placed and at the other end the term "Yes, a lot" or "As much as I have never felt". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark which is scored.

Change in desire for specific types of food

时间窗: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.

The desire to eat specific foods: sweet, salty, fatty, tasty and thirsty, was evaluated with visual analog scales, consisting of lines in which at one end is placed the term "Yes, very much" and at the other end the term "No, not at all". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark, to which a score is given.

Change in ghrelin concentration

时间窗: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.

Ghrelin hormone measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is GHRL/Ghrelin ELISA Kit catalog number ELH-GHRL. Ghrelin is measured in pg/mL.

次要结局

  • Change in plasma glucose(Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.)
  • 24 hour dietary intake recall pre-intervention(Baseline)
  • Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein(Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.)
  • Physical activity(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Livier Nathaly Torres Castillo

Associate Professor B

University of Guadalajara

研究点 (2)

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