The Apple Study: Investigating the Effects of Whole Apple Consumption on Risk Factors for Chronic Metabolic Diseases in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Plasma triglyceride levels
研究概览
简要总结
Obesity is characterized by an underlying inflammatory state in which various inflammatory signaling molecules, termed cytokines, affect metabolic processes central to type 2 diabetes and cardiovascular disease; leading causes of disability and death in Ontario. Such obesity-associated inflammation is partly due to the movement of endotoxin (i.e. lipopolysaccharide (LPS), a cell wall component of Gram-negative bacteria) from the gut microbiota to the blood, resulting in elevated blood levels of LPS (a condition termed metabolic endotoxemia) that stimulates inflammation. Digestion of a high-fat meal increases blood LPS and is subsequently associated with inflammation and metabolic impairments. However, in this context, little is known about how the consumption of bioactive-rich foods, such as whole apples, can improve impaired inflammatory and metabolic responses in overweight and obese individuals. Apples are a key commodity to study given that they are Ontario's predominant fruit crop with the apple industry valued at approximately $400 million, they require little food preparation, and they are common in the diet year-round. There are some, but limited, reports of potential apple-induced health benefits related to reductions in inflammation and improved metabolic responses in lean/healthy individuals, but work in overweight and obese individuals is especially lacking. Thus, to address the gap in our understanding of how daily apple intake may improve the health consequences of obesity, we will conduct a randomized clinical trial in which overweight and obese adults will consume three Ontario-grown Gala apples (approximately 300 g) as part of their typical diet in one sitting (i.e. acute consumption) and/or daily for six weeks (i.e. chronic consumption). The Acute Apple Consumption phase of the study will follow a randomized crossover design in which participants' rate of gastric emptying, efficacy of dietary lipid digestion and absorption, and production of inflammatory cytokines and biomarkers of metabolism will be assessed before and after consuming a high-fat meal (designed to provide 1 g fat/kg body weight) with or without three apples in one sitting. The Chronic Apple Consumption phase of the study will follow a randomized, controlled, parallel-arm design in which participants' (fasting) production of inflammatory cytokines and biomarkers of metabolism, as well as their gut microbiota profile, will be assessed before and after consuming three apples (or no apples) daily for six weeks. We hypothesize that the consumption of three whole apples in one sitting and daily for six weeks will improve these parameters in overweight and obese individuals at risk of developing chronic metabolic diseases.
详细描述
This study will be conducted at the Human Nutraceutical Research Unit (HNRU) at the University of Guelph. The research will be carried out in accordance with the SOPs established by the HNRU, which formalize the Department of Human Health and Nutritional Sciences (HHNS) procedures to ensure that participant safety and comfort are consistently maintained throughout the research process and that university research standards are met. This study will be conducted in compliance with the Tri-Council Policy Statement 2.
Procedure 1 - Recruitment and screening:
A total of 60 participants will be recruited for this study. Interested individuals will complete a 15-minute phone screening questionnaire to assess initial eligibility. If eligible, a 30-minute in-person screening visit to the HNRU will be scheduled to confirm eligibility. Prior to initiation of the in-person screening visit activities, the appropriate consent form will be provided to and discussed with the potential participant, and will be signed. At the in-person screening visit, potential participants will be asked to:
- Complete an in-person screening questionnaire of health and lifestyle habits
- Have anthropometric measures taken, including body weight, height, waist circumference and blood pressure in private area by a study coordinator Next, the Acute and Chronic Apple Consumption phases of the study will be explained to eligible participants, and all questions will be answered. Finally, the appropriate consent form will be provided to and discussed with eligible participants, and will be signed.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 75 years old
- •BMI ≥ 25 kg/m2 and/or waist circumference ≥ 40" for males or ≥ 30" for females
- •Current/prior use of acetaminophen without complications
排除标准
- •Pregnant or breastfeeding females
- •Fasting blood glucose ≥ 7.0 mmol/L
- •Chronic diseases, including by not limited to: type 2 diabetes, cardiovascular disease, liver disease, etc.
- •Gastrointestinal conditions or illnesses, including but not limited to: lactose intolerance, Celiac disease, Crohn's disease, Ulcerative Colitis, Irritable Bowel Disorder
- •Inflammatory conditions or active infection
- •Serious major medical condition requiring hospitalization within the last year
- •Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
- •Taking any natural health products or dietary supplements, other than a multivitamin low in phenolic acids
- •Taking any medication or natural health product contraindicated with acetaminophen
- •Allergy to acetaminophen
- •Use of immunomodulating agents
- •Antibiotic use within last 3 months
- •Alcohol consumption of ≥ 4 drinks/sitting or ≥ 14 drinks/week
- •Use of tobacco products or recreational drugs
研究组 & 干预措施
Acute phase - intervention
Participants will be asked to consume 3 whole apples and a high-fat meal (a mixture of commercially available whipping cream and milk, providing 1 g of fat per kg of body weight) within 30 minutes.
干预措施: Apples (Other)
Acute phase - control
Participants will be asked to consume a high-fat meal (a mixture of commercially available whipping cream and milk, providing 1 g of fat per kg of body weight) within 30 minutes.
Chronic phase - intervention group
Participants will be asked to consume 3 whole apples per day for 6 weeks.
干预措施: Apples (Other)
Chronic phase - control group
Participants will be asked to consume no apples per day for 6 weeks.
结局指标
主要结局
Plasma triglyceride levels
时间窗: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially
Plasma inflammatory cytokine levels
时间窗: Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially
E.g. adiponectin, leptin, IL-1B, IL-6, IL-10, TNF-a, MCP-1, MIP-1a, etc.
Gut microbiota profile
时间窗: Immediately before and after the 6-week Chronic phase of the study
16S rRNA gene sequencing to identify different microbes within fecal samples, representative of the gut microenvironment
次要结局
- Fatty acid composition of chylomicron-rich fraction of blood(For the Acute phase of the study only: fasting and 120, 240, and 360 minutes post-prandially)
- Levels of inflammatory cytokines secreted from peripheral blood mononuclear cells isolated from whole blood samples and stimulated with or without lipopolysaccharide(Fasting, and for the Acute phase of the study only: 240 post-prandially)
- Plasma lipopolysaccharide binding protein(Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially)
- Plasma glucose levels(Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially)
- Plasma ApoB48 levels(For the Acute phase of the study only: fasting and 120, 240, and 360 minutes post-prandially)
- Rate of gastric emptying(For the Acute phase of the study only: fasting and 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially)
- Plasma insulin levels(Fasting, and for the Acute phase of the study only: 20, 40, 60, 80, 100, 120, 140, 160, 180, 240, 300, and 360 minutes post-prandially)
研究者
Lindsay Robinson
Associate Professor
University of Guelph
