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临床试验/NCT03232034
NCT03232034已完成不适用

The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion

University of Bath1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).

研究概览

简要总结

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.

详细描述

Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).

Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.

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
Double (Participant, Investigator)

盲法说明

Participants and Researchers will be blinded to the interventions.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women age between 18-65 yrs.
  • Able to consume provided supplement.
  • Weigh stable for the past 3 month (no change within 3%).

排除标准

  • Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
  • Not between the ages of 18-65 years
  • A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
  • Taking medications that may influence your metabolism
  • Plans to change your lifestyle (diet and/or physical activity) during the study period
  • Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
  • Current smoker

研究组 & 干预措施

Milk Mineral Supplement

Active Comparator

Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.

干预措施: Milk Mineral Supplement (Dietary Supplement)

Milk mineral supplement plus Whey Protein Hydrolysate

Experimental

Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.

干预措施: Milk Mineral Supplement (Dietary Supplement)

Milk mineral supplement plus Whey Protein Hydrolysate

Experimental

Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.

干预措施: Whey Protein Hydrolysate (Dietary Supplement)

Calcium Citrate

Placebo Comparator

Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.

干预措施: Calcium Citrate (Dietary Supplement)

结局指标

主要结局

Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).

时间窗: 120 min

Plasma glucagon-like peptide-1 (GLP-1) concentrations

次要结局

  • Postprandial plasma GIP area under the curve (mmol/L x 120 min)(120 min)
  • Postprandial plasma PYY area under the curve (mmol/L x 120 min)(120 min)
  • Energy metabolism (carbohydrate and fat oxidation)(120 min)
  • Postprandial plasma glucose(120 min)
  • Blood pressure(120 min)
  • Subjective ratings of appetite (au)(120 min)

研究者

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

Javier Gonzalez

Lecturer (Assistant Professor) in Human Physiology

University of Bath

研究点 (1)

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