The Effects of Four Instant Maize Porridges on Satiety Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Satiety -Appetite
研究概览
简要总结
This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability to participate on the test days
- •Interest and consent to participate in the study
- •Participants must be willing to fast 10 hours overnight before the test breakfast meal (only water allowed)
- •Products and meals high in fiber, alcohol and strenuous exercise should be avoided 24 hours before the test
- •Age 18-35 years
- •Healthy BMI: 18.5-24.9 kg/m2
- •Equal split, males and females
排除标准
- •Pregnancy; breast-feeding
- •History of gastrointestinal disease having an impact on food absorption or digestion; anorexia nervosa or bulimia nervosa
- •Hypoglycaemia
- •Cardiovascular disease; elevated plasma glucose; unstable thyroid function
- •Abnormal/irregular menstrual cycle
- •Substance abuse
- •Being on medication which influences appetite
- •Depression; smoking
- •Participation in any weight altering program; weight gain or loss > 5 kg in 3 months prior to enrolment
- •History of intestinal discomfort when consuming relatively small (e.g., <10g) amounts of non-digestible fibres
- •Any known food allergies or intolerances such as wheat or soy; special diets prescribed by medical practitioner
- •Any intensive physical training program
研究组 & 干预措施
Whole grain maize porridge prepared with cold water
White Star Whole Grain Instant Maize Porridge Original
干预措施: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. (Other)
Whole grain maize porridge prepared with hot water
White Star Whole Grain Instant Maize Porridge Original
干预措施: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. (Other)
Smart Food
FUTURELIFE Smart Food Original
干预措施: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. (Other)
Instant Maize Porridge - reduced sugar formulation (WSIP)
White Star Instant Maize Porridge Original- reduced sugar formulation (WSIP)
干预措施: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. (Other)
结局指标
主要结局
Satiety -Appetite
时间窗: On each of four testing days, in fasted state, immediately after the standardised breakfast (0), and at 120 and 240 min after the breakfast
Self-reported appetite ratings using a 100 mm visual analog scale (VAS) questionnaire with 3 items: desire to eat rated from very weak to very strong, hunger rated from not at all to extremely, and fullness rated from not at all to extremely.
Satiety -Biomarkers: Leptin
时间窗: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood by venipuncture to measure the appetite-regulating hormone leptin in nanograms per milliliter
Satiety -Biomarkers: Ghrelin
时间窗: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood by venipuncture to measure the appetite-regulating hormone ghrelin in picograms per milliliter
Satiety - glycaemic parameters: Glucose
时间窗: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood samples obtained by venipuncture in millimoles per liter
Satiety - glycaemic parameters: Insulin
时间窗: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Serum samples obtained by venipuncture in microunits per milliliter
次要结局
- Anthropometric measurements - BMI(Test Day 1 only prior to porridge consumption)
- Anthropometric measurements - WHR(Test Day 1 only prior to porridge consumption)
- Anthropometric measurements - Fat Mass(Test Day 1 only prior to porridge consumption)
- Dietary intake habits-QFFQ(The protocol allows for completion prior to the first test day, or instead at any one of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.)
- Dietary intake habits-24 hour recall(Completed at each of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.)