PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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/m2, will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore 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.
BACKGROUND: 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.
BACKGROUND: Clinical Trial Registry of India (CTRI/2023/03/050421).
METHODS: 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/m2, will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore 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.
BACKGROUND: 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.
BACKGROUND: Clinical Trial Registry of India (CTRI/2023/03/050421).
摘要：
背景：杏仁具有维持肠道健康和调节血糖的益生元潜力。西方研究表明，它们对预防糖尿病和心血管疾病等非传染性疾病的积极作用。然而,缺乏涉及亚洲印第安人的研究，由于他们独特的“亚洲表型”，他们患糖尿病的倾向更高。因此,本研究旨在通过一项随机临床试验,评估补充杏仁对印度农村地区糖尿病前期成人血糖控制和肠道健康的影响.
方法：一项平行整群随机对照试验，包括178名20-50岁的糖尿病前期参与者（1:1），两种性别，体重指数为18.9-25kg/m2，将在Chikkaballapur的农村地区进行，印度的Kolar和班加罗尔农村地区。干预组将接受56克杏仁作为上午16周的零食，而对照组将在研究调查人员的封闭监督下接受基于谷物/脉冲的传统等热量零食。该研究的主要结果是在第16周测量的HbA1c。次要结果-人体测量学，临床和其他生化参数-将在第0点测量，第8周和第16周,一个由120名参与者组成的亚组将接受肠道健康分析。胰高血糖素样肽1分析将在第0周和第16周对30名参与者进行。将使用WindowsV.27.0的SPSS进行统计分析，并进行意向治疗和符合方案分析。
背景：伦理批准获得了Ramaiah医学院的机构伦理委员会，班加罗尔,卡纳塔克邦,印度(DRPEFP7672021)。我们将在筛选并将其纳入研究之前获得参与者的知情书面同意。该试验的结果将通过在同行评审的期刊和科学聚会上发表来传播。
背景：印度临床试验注册（CTRI/2023/03/050421）。
方法：一项平行整群随机对照试验，包括178名20-50岁的糖尿病前期参与者（1:1），两种性别，体重指数为18.9-25kg/m2，将在Chikkaballapur的农村地区进行，印度的Kolar和班加罗尔农村地区。干预组将接受56克杏仁作为上午16周的零食，而对照组将在研究调查人员的封闭监督下接受基于谷物/脉冲的传统等热量零食。该研究的主要结果是在第16周测量的HbA1c。次要结果-人体测量学，临床和其他生化参数-将在第0点测量，第8周和第16周,一个由120名参与者组成的亚组将接受肠道健康分析。胰高血糖素样肽1分析将在第0周和第16周对30名参与者进行。将使用WindowsV.27.0的SPSS进行统计分析，并进行意向治疗和符合方案分析。
背景：伦理批准获得了Ramaiah医学院的机构伦理委员会，班加罗尔,卡纳塔克邦,印度(DRPEFP7672021)。我们将在筛选并将其纳入研究之前获得参与者的知情书面同意。该试验的结果将通过在同行评审的期刊和科学聚会上发表来传播。
背景：印度临床试验注册（CTRI/2023/03/050421）。
