Ramaiah International Centre for Public Health Innovations, Bangalore, Karnataka, India
Ramaiah International Centre for Public Health Innovations, Bangalore, Karnataka, India.
BMJ Open. 2024 Jul 2;14(7):e076934. doi: 10.1136/bmjopen-2023-076934.
Almonds have prebiotic potential to maintain gut health and regulate glycaemia. Western studies have shown their positive effects on preventing non-communicable diseases like diabetes and cardiovascular diseases. However, there is a lack of research involving Asian Indians, who have a higher predisposition to diabetes due to their unique 'Asian phenotype'. Therefore, this study aims to evaluate the impact of almond supplementation on glycaemic control and gut health in adults with pre-diabetes in rural India through a randomised clinical trial.
A parallel cluster randomised controlled trial with 178 participants with pre-diabetes (assigned 1:1) aged 20-50 years, of both genders, with a body mass index of 18.9-25 kg/m, will be conducted in rural areas of , and districts in India. The intervention group will receive 56 g of almonds as mid-morning snacks for 16 weeks, while the control group will receive cereal/pulse-based traditional isocaloric snacks under the closed supervision of the study investigators. The primary outcome of the study is HbA1c measured at the 16th week. The secondary outcomes-anthropometry, clinical and other biochemical parameters-will be measured at 0th, 8th and 16th weeks, and a subgroup of 120 participants will undergo gut health analysis. Glucagon-like peptide 1 analysis will be conducted on 30 participants at 0th and 16th weeks. Statistical analysis will be performed using SPSS for Windows V.27.0, and both intention-to-treat and per-protocol analyses will be conducted.
Ethics approval was obtained from the Institutional Ethics Committee at Ramaiah Medical College, Bangalore, Karnataka, India (DRPEFP7672021). We will obtain the informed written consent of the participants prior to screening and enrolling them in the study. Results from this trial will be disseminated through publication in peer-reviewed journals and scientific gatherings.
Clinical Trial Registry of India (CTRI/2023/03/050421).
杏仁具有益生元潜力，可以维持肠道健康并调节血糖。西方的研究表明，它们对预防非传染性疾病（如糖尿病和心血管疾病）有积极作用。然而，由于亚洲人的独特“亚洲表型”，他们更容易患上糖尿病，因此涉及亚洲印度人的研究较少。因此，本研究旨在通过一项随机临床试验，评估杏仁补充剂对印度农村地区患有糖尿病前期的成年人的血糖控制和肠道健康的影响。
这是一项平行的集群随机对照试验，将纳入 178 名年龄在 20-50 岁、性别不限、BMI 在 18.9-25kg/m²之间、患有糖尿病前期的成年人（按 1:1 比例分配），并在印度的 、 和 地区的农村地区进行。干预组将在 16 周内接受 56 克杏仁作为上午加餐，而对照组将在研究调查人员的密切监督下接受谷物/豆类传统等热量零食。研究的主要结局是第 16 周时的 HbA1c 测量值。次要结局-人体测量学、临床和其他生化参数-将在第 0 周、第 8 周和第 16 周进行测量，并且将对 120 名参与者进行肠道健康分析。将在第 0 周和第 16 周对 30 名参与者进行胰高血糖素样肽 1 分析。将使用 SPSS for Windows V.27.0 进行统计分析，并进行意向治疗和方案分析。
该研究已获得印度班加罗尔 Ramaiah 医学院机构伦理委员会的批准（DRPEFP7672021）。在筛选和招募参与者之前，我们将获得他们的知情书面同意。本试验的结果将通过发表在同行评议的期刊和科学会议上进行传播。
印度临床试验注册中心（CTRI/2023/03/050421）。
