Obesity, Body Fat Distribution, and Cancer Risk in the Multiethnic Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change from Baseline Visceral adipose tissue (VAT) at 12 weeks
研究概览
简要总结
This pilot study aims to develop a study design to test the difference between a fasting diet and a heart healthy diet, assess participants' adherence to the study design, and to test whether either diet helps to reduce fat wrapped around the organs in the stomach area and total body fat in East Asian American adults. 70 men and women residents of Oahu Hawai'i, aged 35-55, who are overweight or obese and have moderate to high amounts of fat around organs in the stomach area, of Japanese, Chinese, or Korean ancestry, will be equally distributed to either the fasting diet or the heart healthy diet and asked to follow this diet for the 12-week study. Each diet has set requirements for energy, protein, carbohydrates, and fat. The fasting diet has two days of fasting, where participants will be asked to follow a low carbohydrate- low energy diet, and five days of a balanced diet without any energy restriction (the Mediterranean diet). The other group will follow a heart healthy diet (Dietary Approaches to Stop Hypertension diet) for all seven days without any energy restriction. Both groups will be asked to follow a moderate exercise program (one hour of walking five days a week). Dietitians will provide information on diet and exercise requirements to the participants at the start of the study. Dietitians will contact the participants seven times, primarily by phone, to offer support and to check if the participants are following prescribed diet and exercise plans. Participants will use a mobile phone app to take images of all foods and drinks for four days at the beginning, middle and end of the 12-week study. Body measurements, including measurements of body fat, will be taken at the beginning and end of the study by trained clinic staff. The analysis of the food images, participants' self-reported compliance to diet and exercise plans, and body measurements will be used to determine if the study design and participant compliance to the study are successful, and to assess which diet is better at reducing total body fat and fat around the organs in the stomach region.
详细描述
Background and rationale: East Asian adults are known to have higher levels of visceral adiposity than whites, African Americans, and Hispanic adults in the US. This visceral fat deposition, because of its close proximity to the portal vein, has greater metabolic activity and is associated with a greater risk of cardiometabolic diseases and possibly certain cancers (e.g., breast and colorectal cancers). Newly introduced weight loss interventions, specifically, intermittent energy restriction (IER), have been proposed to be as effective as continuous energy restriction, achieve higher and long-term compliance, and may predominantly result in a decrease in visceral fat. Thus, implementing this novel weight loss intervention among East Asian Americans with high visceral fat deposition would be particularly beneficial .
Goal: This study aims to demonstrate the feasibility to conduct an intermittent energy restriction (IER) nutritional intervention aimed at reducing visceral adiposity in overweight Asian Americans middle-aged adults.
- To finalize and implement a protocol for an IER intervention plus exercise with the goal of reducing visceral fat in overweight adult East Asian Americans (EAA). The protocol will include an intensive dietary intervention and an exercise program administered by a dietitian through individual meetings and the use of new technologies to monitor dietary compliance.
- After eligibility screening, 70 individuals will be randomized to either the intensive intervention diet group or to a non-intensive intervention (active comparator) diet group for 12 weeks. The intensive intervention group will follow a low carbohydrate- low energy IER diet for two consecutive days, and the Mediterranean (MED) diet for the other five days and meet estimated energy requirements (IER + MED group). The active comparator group will follow the Dietary Approaches to Stop Hypertension (DASH) diet for all seven days and meet estimated energy requirements (DASH group). With an expected attrition rate of ~25%, the investigators expect ~50 participants to complete the study.
- To evaluate study retention, protocol adherence, effect size of the intervention on body weight, total adiposity, DXA measured visceral fat (main outcome), estimated visceral adipose tissue area, and selected clinical measures (e.g., waist circumference, hip circumference).
Design: Randomized lifestyle intervention trial to compare the effects of two twelve-week diets - (i) an IER + MED diet versus (ii) DASH diet- on DXA quantified visceral fat deposition distribution in overweight/obese men and women. Both intervention groups will be asked to follow a moderate exercise program (1 hour of walking five days a week). The research will be carried out in the University of Hawaii Cancer Center (UHCC). The investigators will determine and compare the primary and secondary endpoints at least five days after the last 2 energy-restricted days to a corresponding day of the week in the DASH group at the completion of the 12th week of IER+MED or DASH diets.
Assessing dietary intervention adherence: Dietary intake of energy, fat (monounsaturated fatty acids (MUFA), Polyunsaturated fatty acids (PUFA) and saturated fat), carbohydrate, protein, dietary fiber and alcohol will be assessed prior to the first week of intervention, the 5-6th week, and the 12th week. Participants will capture images of foods eaten and consumed over four days (i.e., before and after images of each eating occasion). A mobile app designed to seamlessly take images of foods/beverages will be loaded to onto each participant's mobile telephones for free and removed at the end of the study. Physical activity level will be assessed at baseline using a physical activity questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be provided with healthful dietary information but will not be told what diets their diet plans are based on. Participants in the IER+MED diet group will be told they are on diet plan 1 and participants in the DASH diet group will be told they are on diet plan A. The research dietitians will know which diet plan each participant is on, however; all other clinic staff who assess outcomes measures will be blinded to each participant's diet group.
入排标准
- 年龄范围
- 35 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25-40
- •No serious health issues
- •Normal blood chemistry profile
- •VAT ≥90cm2 for men and ≥80cm2 for women
- •Japanese, Chinese, or Korean ancestry
- •Resident of Hawaii.
排除标准
- •Reported smoking tobacco products or marijuana in the past 2 years
- •Taking medication for Type 1 or Type 2 diabetes
- •Reported taking thyroid medication.
研究组 & 干预措施
IER+MED group
The IER+MED group intervention will be to restrict 70% energy (34%, 33% and 33% distribution of protein, carbohydrate, and fat, respectively) on 2 days and follow the MED diet (25%, 45%, 30%) and meet their estimated energy requirement (EER) for the other 5 days each week. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
干预措施: IER+MED group (Behavioral)
DASH group
The DASH group intervention will be to follow the DASH diet and meeting a distribution of macronutrients of 20% protein, 53% carbohydrate, and 30% fat and meet their EER. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
干预措施: DASH group (Behavioral)
结局指标
主要结局
Change from Baseline Visceral adipose tissue (VAT) at 12 weeks
时间窗: Change from baseline VAT at 12 weeks
VAT (cm2) measured at L4-L5 with Dual-energy X-ray absorptiometry (DXA)
次要结局
- Change from Baseline Resting Energy Expenditure (REE) at 12 weeks(Change from baseline REE at 12 weeks)
- Change from Baseline Blood Biomarkers at 12 weeks(Change from baseline blood biomarkers at 12 weeks)
- Change from Baseline DXA Subcutaneous Fat and Total Adiposity at 12 weeks(Change from baseline subcutaneous fat and total adiposity at 12 weeks)
- Change from Baseline Lean Body Mass at 12 weeks(Change from baseline lean body mass at 12 weeks)
研究者
Carol J Boushey
Associate Research Professor
University of Hawaii
