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临床试验/NCT02277275
NCT02277275已完成不适用

Effects of a BCAA-supplemented Hypocaloric Diet Versus a Standard Hypocaloric Diet on Weight Loss, Lean Mass Preservation and Improvement of Insulin Sensitivityand Its Benefits Over a High-protein Hypo-caloric Diet.

National University of Singapore2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
Changes in body compostion(i.e muscle mass, fat mass) by DEXA scan measurements

研究概览

简要总结

High-protein diets better preserve lean mass than conventional low-fat diets. However, they are costly and have potential health risks. Preserving lean mass is important for sustaining high resting energy expenditure, leading to greater initial weight loss, better weight maintenance and improving blood sugar levels. Branched-chain amino acids (BCAA) supplements are known to preserve lean mass but their effects during weight loss have not been examined. Investigators want to investigate if a BCAA-supplemented diet is more effective than a standard hypocaloric diet in terms of the aforementioned benefits, and yet has less detrimental effects than a high-protein diet for weight loss. Using a 16-week weight loss and 8-week weight maintenance intervention, overweight and obese men and women will be randomized to either a hypocaloric diet with BCAA or placebo supplements or a high-protein diet with placebo supplements. Participants' compliance to the diet versus supplements will be compared. Body composition, resting and diet-induced energy expenditure, insulin sensitivity will be measured and blood samples taken before and after weight loss. These findings will inform on the benefits of BCAA-supplementation during energy restriction and may offer an alternative cost-effective strategy for weight loss and maintenance, without the adverse health effects of a high-protein load.

详细描述

The prevalence of obesity globally and in Singapore continues to rise despite increased public awareness and efforts to control weight. Its association with chronic metabolic diseases, including diabetes, hypertension, cardiovascular diseases, signify the serious implications of obesity on public health. There remains, however, no scientific consensus on the optimal methods for weight loss and its maintenance over longer periods of time. The Atkins diet was introduced in the late 1990s and has since fuelled the popularity of using high-protein diets for weight loss. Scientific evidence have since shown high-protein diets to be more effective than conventional low-fat, high-carbohydrate diets in producing greater weight loss, at least in the short-term. More importantly, high-protein diets also reduce the amount of lean tissue lost during weight loss and may help to maintain weight loss to a greater extent than conventional diets. However, high-protein diets are also known to raise esterol, albeit improving TG and HDL-cholesterol levels. This could be due to the higher amounts of saturated fats that accompany foods rich in animal protein. In addition, high-protein diets may lower bone mineral density and impact on kidney function. High-protein diets are also more expensive than conventional low-fat, high carbohydrate foods , which is an important consideration for longer term compliance.

Supplements containing branched-chain amino acids (BCAA:leucine, isoleucine and valine) are commonly used among muscle builders and athletic community. BCAAs have been shown to stimulate protein synthesis and preserve lean mass. While a few studies have examined BCAA supplementation with low protein diets for weight loss and found depletion of other essential amino acids, the effects of BCAA supplementation with moderate-protein hypocaloric diets on lean mass preservation during weight loss in energy-restricted obese patients has, to our knowledge, not been investigated. Compared to consuming a high (animal) protein diet, which is also rich in BCAAs, taking BCAA supplements would be a much more convenient and affordable way to obtain similar if not greater quantities of BCAA, without the adverse health effects of a high-protein load on the body.

In this study investigators primarily aim to investigate in overweight/obese subjects, whether a BCAA-supplemented (moderate-protein) hypocaloric diet (BCAA) when compared to a standard (moderate-protein) hypocaloric diet (CT) will result in greater lean mass preservation, resting and diet-induced energy expenditure, and improved insulin sensitivity. Investigators will also examine the effects on lean mass preservation and insulin sensitivity changes between BCAA-supplemented diet and high-protein hypocaloric diet (HP). As a secondary aim, investigators have also powered the study to examine if the BCAA-supplemented diet has added advantage to the high-protein diet by incurring less negative effects on bone mineral density and renal function.

In addition, investigators will determine the participant's compliance to the diet versus supplements as a weight loss and maintenance strategy. The findings of this study will provide us novel insight on BCAA-supplementation in the hypocaloric diet. If this study is successful, BCAA-supplementation on a hypocaloric diet could provide an alternative to a standard (moderate-protein) hypocaloric diet for weight reduction strategy without the attending potential health risks of a high protein load e.g. reduced bone mineral density and detrimental effects on renal function.

There are three main hypotheses which investigators propose to examine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be willing and able to comply with study procedures and given written informed consent
  • Chinese, aged 21-45 years old
  • Body mass index (BMI) between 25 -35 kg/m2 and % body fat of more than 25 %.
  • Sedentary adults, with <1 episode of exercise per week
  • Not have a history of food allergies or food intolerances
  • Have maintained a stable body weight for at least 3 months prior to the study.
  • Be a non-smoker
  • Drinks less than 3 caffeinated beverages per day (coffee/tea/energy drinks)
  • Drinks less than 3 units of alcohol per day

排除标准

  • Subjects with diabetes, renal impairment, high blood pressure, gastrointestinal problems, asthma, eczema, anaemia or on medications that will affect glucose metabolism (e.g. corticosteroids) or lipid metabolism/insulin resistance (e.g. niacin, fibrates, metformin) and other significant medical conditions, which in the investigator's opinion would confound interpretation of results.
  • Recent changes (gain or loss) in weight of >5% over the past 3 months
  • Significant changes in diet over the past 3 months
  • Any use of weight-reduction drugs in the past 6 months
  • Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry
  • Have special dietary needs/restrictions e.g. vegetarian diet or unable to consume fish, seafood and beef
  • History of eating disorders or irregular eating habits
  • High level of physical activity (exercise > 5hr per week)
  • Women who are pregnant and lactating and women of reproductive age group who plan to conceive within 6 months. A pregnancy test will be performed for women in the reproductive age group.
  • Have contraindications to Magnetic Resonance Imaging (MRI) that includes metallic implants, pacemakers or stimulators, or any other methodology applied in the study.
  • Have been involved in any clinical or food study within the preceding month.
  • Presently consuming amino acid or protein-related supplements.

研究组 & 干预措施

Standard protein diet with placebo

Placebo Comparator

Subjects will be provided with standard protein diet for four months and corn starch pills(Placebo) for 6 months

干预措施: Placebo (Dietary Supplement)

Standard protein diet with BCAA

Experimental

Branched chain amino acid(BCAA) pills will be provided to subjects 0.15g/kg of body weight per day for six months, standard protein diet will be provided for four months

干预措施: BCAA (Dietary Supplement)

High protein diet with placebo

Placebo Comparator

Subjects will be provided with high protein diet for four months and corn starch pills(Placebo) for 6 months

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Changes in body compostion(i.e muscle mass, fat mass) by DEXA scan measurements

时间窗: Week 0, 16 and 24

lean mass, fat mass

次要结局

  • inflammatory markers and gene expressions of PBMC(week 0, 16, 24)
  • Changes in resting and diet-induced energy expenditure(Week 0, 16 and 24)
  • Changes in insulin resistance(Week 0, 16 and 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee Yung Seng

Associate Professor

National University of Singapore

研究点 (2)

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