An open-label clinical trial to investigate the safety and efficacy of a bone broth diet on weight loss in adults with obesity

Q3 Nursing
Katarina M. Doma, Marc Moulin, Huda Al-Wahsh, Najla Guthrie, David C. Crowley, Erin D. Lewis
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引用次数: 0

Abstract

Background and aims

Over 40% of North American adults are obese and with rates increasing, an already significant public health concern is expected to get worse. Modifiable risk factors such as poor dietary habits represent an opportunity for targeted change. The Bone Broth Diet (BBD) combines the consumption of bone broth, portion-controlled, low carbohydrate and high protein meals, intermittent fasting, and exercise.

Methods

This open-label, single-arm clinical trial investigated the safety and efficacy of the BBD on weight loss in adults with obesity between 35–65 years old. Participants (n = 100) completed two, 3-week periods of 5:2 intermittent fasting (BBD 1 and 2), while consuming bone broth, for which each period was followed by a one-week maintenance period. Body weight, body composition, anthropometrics, metabolic blood markers, satiety and hunger, quality of life, and safety were assessed over the study period.

Results

There were respective decreases of 4.8 kg and 2.6 kg in body weight after BBD 1 and 2 which corresponded to 5.0% and 2.7% (P < 0.001), respectively. Both BBD phases were followed by periods of weight maintenance. These improvements corresponded with decreases in fasting blood glucose, waist circumference, and sagittal abdominal diameter (P ≤ 0.005). There were decreases in hunger and cravings (P < 0.05) with no reduction in satisfaction after eating over the study period (P > 0.05). The BBD was safe and tolerated in the studied population.

Conclusion

The BBD showed safe, statistically significant and clinically relevant weight loss with corresponding improvements in cardiometabolic and psychological health outcomes in a population of adults with obesity who were otherwise healthy. Findings suggest this lifestyle program may aid in addressing an important public health concern. However, future randomized controlled trials of longer duration are recommended to verify and understand the sustainability of results.

Clinical trial registration

This study is registered at clinicaltrials.gov (NCT05740670).
一项开放标签临床试验,研究骨汤饮食对肥胖成人减肥的安全性和有效性
背景和目的超过40%的北美成年人肥胖,而且随着肥胖率的上升,本已严重的公共卫生问题预计会变得更糟。不良饮食习惯等可改变的风险因素为有针对性的改变提供了机会。骨汤饮食法(BBD)结合了骨汤的摄入、控制份量、低碳水化合物和高蛋白膳食、间歇性禁食和锻炼。方法:这项开放标签、单臂临床试验研究了BBD对35-65岁肥胖成人减肥的安全性和有效性。参与者(n = 100)完成了两、三周的5:2间歇性禁食(BBD 1和2),同时食用骨汤,每一段时间之后是一周的维持期。在研究期间,对体重、身体成分、人体测量、代谢血液指标、饱腹感和饥饿感、生活质量和安全性进行了评估。结果BBD 1、2后体重分别下降4.8 kg和2.6 kg,分别为5.0%和2.7% (P <;分别为0.001)。两个BBD阶段之后都是体重维持期。这些改善与空腹血糖、腰围和矢状腹径的降低相对应(P≤0.005)。饥饿感和渴望减少(P <;0.05),在研究期间,进食后的满意度没有下降(P >;0.05)。在研究人群中,BBD是安全且耐受的。结论:在健康的成年肥胖人群中,BBD显示出安全、具有统计学意义和临床相关性的体重减轻,并相应改善了心脏代谢和心理健康结果。研究结果表明,这种生活方式计划可能有助于解决一个重要的公共健康问题。然而,建议将来进行更长时间的随机对照试验,以验证和了解结果的可持续性。临床试验注册本研究已在clinicaltrials.gov注册(NCT05740670)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical Nutrition Open Science
Clinical Nutrition Open Science Nursing-Nutrition and Dietetics
CiteScore
2.20
自引率
0.00%
发文量
55
审稿时长
18 weeks
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