WHNRC (Western Human Nutrition Research Center) Honey Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in postprandial glucose response
研究概览
简要总结
The purpose of this research is to compare two snacks, one with honey and nuts and the other with sugar and nuts, on glucose levels before and after eating these snacks.
The investigators hypothesize that honey and nuts will have an additive effect on the reduction of postprandial glucose response. The investigators further hypothesize that consumption of honey paired with nuts will retain the benefit of sugar consumption in satiety and reduction of metabolic stress.
详细描述
Consuming sugar creates a feeling of satiation, and may buffer metabolic stress. However, prolonged postprandial hyperglycemia has been identified as a potential risk factor in type 2 diabetes and cardiovascular disease. Nuts, which are recommended to be consumed as part of a Mediterranean diet, up to 2 servings per day, have been shown to dramatically reduce postprandial glucose response to carbohydrates. Additionally, honey, which is typically used as an added sugar within a Mediterranean diet pattern, has a lower glycemic index than table sugar and may result in a reduced postprandial glucose response relative to other nutritive sweeteners. However, it is not yet known whether honey can work additively with nuts to further reduce postprandial glucose response over the reduction caused by nuts alone.
Honey has been shown to produce equivalent or greater satiety to regular table sugar and there is some indication that honey can improve immediate/working memory. Therefore, combined consumption of honey and nuts may offer a way to maximize the benefits of carbohydrate consumption on satiety and metabolic stress reduction while minimizing its negative effects on metabolism. However, it is not yet known whether sugars contained in the more complex food matrix of honey, consumed together with a food like nuts can impact satiety and metabolic stress in the way that has been observed for sugar.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women must be pre-menopausal
- •Willing to consume snacks that contain honey, table sugar, and tree nuts
排除标准
- •Body Mass Index (BMI) <18.5 or >40
- •Allergies to tree nuts
- •Current medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal diseases, cancer, type 1 or type 2 diabetes, thyroid disease requiring medication, inflammatory or irritable bowel diseases, or those with recent major surgeries
- •No individuals who fall in to the vulnerable categories of adults including those unable to consent, pregnant women, children, or prisoners will be eligible for this study
- •Routinely taking medications known to affect glucose response.
- •Caffeine and alcohol use will not be excluded, but should be carefully reported by each subject.
- •Regarding female candidates:
- •Post-menopausal
- •Women who have been pregnant or nursing within the last 6 months or plan to become pregnant during the trial will be ineligible
研究组 & 干预措施
Sucrose alone and sucrose with almonds, then honey alone and honey with almonds
Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Honey (Other)
Honey alone and honey with almonds, then sucrose alone and sucrose with almonds
Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Honey plus almonds (Other)
Honey alone and honey with almonds, then sucrose alone and sucrose with almonds
Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Sucrose plus almonds (Other)
Sucrose alone and sucrose with almonds, then honey alone and honey with almonds
Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Honey plus almonds (Other)
Sucrose alone and sucrose with almonds, then honey alone and honey with almonds
Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Sucrose plus almonds (Other)
Honey alone and honey with almonds, then sucrose alone and sucrose with almonds
Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Honey (Other)
Honey alone and honey with almonds, then sucrose alone and sucrose with almonds
Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Sucrose (Other)
Sucrose alone and sucrose with almonds, then honey alone and honey with almonds
Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
干预措施: Sucrose (Other)
结局指标
主要结局
Change in postprandial glucose response
时间窗: Measured continuously over days 0-8 and 23-31
Interstitial glucose response measured by a continuous glucose monitor
次要结局
- Change in Self-reported nausea(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Self-reported hunger(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Self-reported fullness(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Self-reported desire to eat(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Self-reported satisfaction with snack(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Cognitive testing for Paired Associates Learning(Days 4, 8, 27, and 31)
- Change in Salivary cortisol(Day 0 and 23 fasting only. Days 4, 8, 27, and 31 at fasting, 30, 60 and 90 min after consumption of snack provided in standard breakfast)
- Change in Self-reported prospective consumption(Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31)
- Change in Cognitive testing for Spatial Working Memory(Days 4, 8, 27, and 31)
- Change in Cognitive testing for Rapid Visual Processing(Days 4, 8, 27, and 31)
- Change in Stool marker of inflammation(Stool collected on study days 0, 4, 8, 23, 27, and 31)
- Assessment of Fasted Salivary Estradiol(Days 0, 4, 8, 23, 27,and 31 at fasting only)
- Assessment of Fasted Salivary Progesterone(Days 0, 4, 8, 23, 27,and 31 at fasting only)
- Change in Dietary Intake(Days 1-3, 5-7, 24-26, and 28-30)
- Change in Stool bacterial metagenomics(Stool collected on study days 0, 4, 8, 23, 27, and 31)