Dietary Intervention for Visceral Adiposity-Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in abdominal adiposity measured by CT
研究概览
简要总结
The purpose of this research study is to determine whether increased intake of dietary fiber during a 12-week, low-calorie weight loss intervention affects abdominal fat change and improves cardiovascular risk factors in African-American women more than a standard weight loss intervention.
The investigators are testing two main hypothesis:
Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more abdominal fat around their organs than women in the standard fiber group.
Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to women in the control group.
详细描述
OBJECTIVES:
Specific Aim 1: To test, in a small clinical trial of 30 pre-menopausal African American women, whether increased intake of dietary fiber embedded in a 12 week weight loss intervention will reduce VAT accumulation more than a standard weight loss intervention.
Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more VAT than women in the standard fiber group.
Specific Aim 2: To test, in a small clinical trial of 30 pre-menopausal African American women, whether increased intake of dietary fiber embedded in a 12 week weight loss intervention will improve cardiovascular risk factors more than a standard weight loss intervention.
Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to women in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal
- •Self-identified as an African-American woman
- •Aged 20-50 years
- •Willing and able to provide informed consent
- •No contraindication to weight loss
排除标准
- •Diabetes or currently taking medication to lower blood sugar
- •Currently on lipid lowering medications
- •Currently taking chronic steroids
- •Current diagnosis of kidney or heart failure
- •Untreated hypothyroidism or hyperthyroidism
- •BMI < 30 kg/m2 or waist circumference < 88 cm
- •Current fiber supplementation
- •Current pregnancy
- •Body mass > 140 kg (CT limit)
- •Inability to speak or read English
- •Gastrointestinal disorders that prohibit the increased consumption of fiber
- •Current participation in a structured weight loss/diet intervention program
- •Inability to consume artificial sweeteners
- •Inability or unwillingness to travel to the CRU during operating hours at the required frequency.
研究组 & 干预措施
Study prepared meals and placebo
Participants will have meals designed specifically for them based on their caloric needs. Participants will choose a weeks worth of meals (from a menu) and pick them up from the Clinical Research Unit twice a week. Participants will not receive any fiber (Benefiber) supplementation in their TrueLemon mixture.
干预措施: TrueLemon (Dietary Supplement)
Nutritional Counseling with fiber
Participants receiving nutritional education will have two individual sessions (spaced approx. 2 weeks apart). The nutritional sessions will focus on knowledge, self-regulation, motivation, experience and environment. Participants will receive fiber (Benefiber) supplementation as the fiber intervention in their TrueLemon mixture .
干预措施: Benefiber (Dietary Supplement)
Nutrition counseling and placebo
Participants receiving nutritional education will have two individual sessions (spaced approx. 2 weeks apart). The nutritional sessions (interventions) will focus on knowledge, self-regulation, motivation, experience and environment.Participants will receive no fiber supplementation in their TrueLemon mixture .
干预措施: TrueLemon (Dietary Supplement)
Study prepared meals and fiber
Participants will have meals designed specifically for them based on their caloric needs. Participants will choose a weeks worth of meals (from a menu) and pick them up from the Clinical Research Unit twice a week. Participants will receive fiber (Benefiber) supplementation as the fiber intervention in their TrueLemon mixture.
干预措施: Benefiber (Dietary Supplement)
结局指标
主要结局
Change in abdominal adiposity measured by CT
时间窗: 12 weeks
Change in area of three abdominal fat depots,namely visceral,subcutaneous and liver fat.
次要结局
- Change in metabolic risk factors(12 weeks)