Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin resistance as estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
研究概览
简要总结
Sorghum is a nutrient-dense ancient grain that, when eaten as a whole grain, provides health-beneficial dietary fiber, protein, and phenolics. The goal of this clinical trial is to learn about the phenolic-dependent and independent effects of whole grain sorghum in adults with excess body weight. The main questions it aims to answer are:
- Are markers of immune and metabolic health affected differently by eating high- vs low-phenolic whole grain sorghum?
- Does the gut microbiome respond differently to eating high- vs low-phenolic whole grain sorghum, and does this response explain the health effects?
Researchers will compare foods made from (1) whole grain sumac sorghum (high phenolic profile), (2) whole grain white sorghum (low phenolic profile), and (3) white rice (control) randomly to identify the health benefits of sorghum relative to white rice.
Participants will:
- Consume three study foods daily during three intervention phases, with each phase lasting four weeks. The three study foods will be a cereal, crispy breadstick, and grain pouch product, which will be made from one of the study grains (sumac sorghum, white sorghum, or white rice).
- Complete questionnaires asking about demographic, diet, lifestyle, quality-of-life, health, and gut health information.
- Have height, weight, waist circumference, body composition, and blood pressure measured.
- Wear a continuous glucose monitor 3 times, each for 10 days.
- Have six blood draws, one saliva sample collection, and provide six stool samples.
- Maintain a study journal during the three intervention phases.
详细描述
Whole grain sorghum is a nutrient-dense, climate-resilient cereal grain that contains dietary fiber, protein, and bioactive compounds such as phenolics, which may beneficially influence gut microbiota and host immunometabolism. However, evidence from well-controlled human randomized controlled trials (RCTs) remains limited, particularly regarding how sorghum varieties with distinct phenolic profiles differentially affect metabolic health and the gut microbiome.
This study is a randomized, three-phase crossover dietary intervention trial designed to evaluate the phenolic-dependent and independent effects of whole grain sorghum consumption in adults with excess body weight. Participants will consume foods made from (1) whole grain sumac sorghum (high phenolic profile), (2) whole grain white sorghum (low phenolic profile), and (3) white rice (control), in random order.
The study consists of a baseline phase of up to two weeks, followed by three 4-week intervention phases separated by washout periods of at least three weeks. During each intervention phase, participants will consume three study foods daily: ready-to-eat cereal, crispy breadsticks, and pre-cooked grain pouches, providing approximately 84 g/day of the study grain. Clinical, metabolic, and microbiome-related outcomes will be assessed through repeated biospecimen collection and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the age of 19 and 64 years.
- •Not currently pregnant or planning to become pregnant (females only).
- •Stable body mass index above or equal to 26 kg/m² (rounded up) for the last month.
- •Body fat above or equal to 36% (female) or 25% (male) (rounded up).
- •No major diet changes in the last month.
- •Ability to eat provided study foods each day and avoid eating sorghum except for the study foods.
- •Ability to wear a continuous glucose monitor for 10 days.
- •Ability to have blood drawn after ~12 hours of fasting.
- •Have a bowel movement at least every third day.
- •Ability to collect and deliver your stool samples to the study site within 4 hours of collection.
- •No known allergies or intolerance to sorghum or rice.
- •No known allergies to wheat or soy (study foods may contain wheat or soy)
- •Able to read and speak English.
- •Requires no legally authorized representative (LAR).
- •Not institutionalized (e.g., prison, psychological treatment center, etc.).
排除标准
- •Has cardiac device or history of organ transplant.
- •History of cancer within the last year (excludes skin cancer).
- •History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines.
- •Current use of tobacco.
- •Excessing alcohol use (≥8 drinks [female] or ≥15 drinks [male] per week).
- •Taken antibiotics in the last 2 months.
- •Current long-term use of anti-diabetic, anti-inflammatory, or cholesterol-lowering medications.
- •Medication regimen or dosage changed within the last 2 months.
- •Use of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements within the last 3 weeks.
- •Supplement regimen or dosage changed within the last 3 weeks
研究组 & 干预措施
Intervention Scheme 1
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 1
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 1
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
Intervention Scheme 2
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 2
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 2
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
Intervention Scheme 3
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 3
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 3
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
Intervention Scheme 4
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 4
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 4
Intervention Phase 1: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
Intervention Scheme 5
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 5
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 5
Intervention Phase 1: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
Intervention Scheme 6
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain sumac sorghum (Other)
Intervention Scheme 6
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: Whole grain white sorghum (Other)
Intervention Scheme 6
Intervention Phase 1: Weeks 1-4: White rice as cereal, breadsticks, and grain pouch.
Intervention Phase 2: Weeks 1-4: Whole grain white sorghum as cereal, breadsticks, and grain pouch.
Intervention Phase 3: Weeks 1-4: Whole grain sumac sorghum as cereal, breadsticks, and grain pouch.
干预措施: White rice (Other)
结局指标
主要结局
Insulin resistance as estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
时间窗: From baseline to the end of treatment at 4 weeks.
Changes in circulating levels of glucose (Unit: mg/dL) and insulin (Unit: uIU/mL) when collected after fasting. Glucose and insulin values will then be used to calculate the Homeostasis Model Assessment of Insulin Resistance using the equation previously described by Matthews and colleagues.
次要结局
- Beta cell function as estimated by the Homeostatic Model Assessment for beta-cell function (HOMA-%B).(From baseline to the end of treatment at 4 weeks.)
- Interstitial glucose dynamics by continuous glucose monitoring(Continuously over a 10 day period during the treatment weeks.)
- Lipid metabolism assessed by a lipid panel(From baseline to the end of treatment at 4 weeks.)
- Systematic inflammation assessed by C-reactive protein(From baseline to the end of treatment at 4 weeks.)
- Systematic inflammation assessed by glycosylated acute-phase proteins (GlycA)(From baseline to the end of treatment at 4 weeks.)
- Systematic inflammation assessed by interleukin-6(From baseline to the end of treatment at 4 weeks.)
- 16S rRNA gene amplicon sequencing of the fecal bacterial community(From baseline to the end of treatment at 4 weeks.)
- Fecal short-chain fatty acids assessed by gas chromatography(From baseline to the end of treatment at 4 weeks.)
- Fecal pH assessed by pH meter(From baseline to the end of treatment at 4 weeks.)
- Fecal dry mass assessed by oven-drying(From baseline to the end of treatment at 4 weeks.)