CTRI/2026/01/100551尚未招募不适用
Comparative Evaluation of Hydration Efficacy (Beverage Hydration Index: BHI) of an Electrolyte Beverage Containing Isomaltulose Versus an Electrolyte Beverage Containing Sucrose in Healthy Adults and Patients with Type-2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Healthy Adult Population
研究概览
简要总结
Three experimental arm (period) study will be conducted in randomized, single-blind (participants), cross-over fashion for two populations; euhydrated healthy adults and patients with type-2 diabetes mellitus. The primary purpose of this study will focus on the evaluation of hydration efficacy of an electrolyte beverage containing isomaltulose and compare it to one containing sucrose in both healthy adults and patients with Type 2 Diabetes Mellitus (T2DM). Secondary purpose will include analyzing metabolic responses of isomaltulose beverage such as blood glucose, plasma insulin, and plasma lactate levels, as well as net fluid balance and to compare with that of sucrose beverage and water in both the population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Adult Population
- •Participant has signed and dated informed consent document before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study.
- •Participant is able to read and understand the local language.
- •Adults with age range of 18 to 30 years.
- •Healthy adults with no known interfering/limiting conditions as judged by the PI based on detailed Medical History
- •Participants with Body Mass Index: BMI 18.5–22.9 kg/m
- •Participants with USG less than or equal to 1.025 (at arrival of each testing period).
- •The participant should refrain from tobacco and caffeine usage for at least 12 hours, from consuming alcohol and from participating in strenuous physical activity for at least 24 hours prior to each experimental period.
- •The participant is able to comprehend the requirements of the study (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol.
- •Patients with T2DM
- •Diagnosed with T2DM for more than or equal to 12 weeks; treated with metformin with or without sulfonylureas at a stable dose for more than or equal to 12 weeks.
- •Participants with Body Mass Index: BMI 18.5 – less than 35 kg/m
- •Participant with USG less than or equal to 1.025 (at arrival of each testing period).
- •Participant with HbA1c of 6.5percent–9percent.
- •The participant refrained from tobacco and caffeine usage for at least 12 hours, from consuming alcohol and from participating in strenuous physical activity for at least 24 hours prior to each experimental period.
- •Patients with T2DM who does not have comorbidities or who have co-existing stable conditions commonly seen in this population, as listed below: o Fairly-controlled hypertension (e.g., BP less than 150/100 mmHg with or without medication).
- •o Stable cardiovascular disease (e.g. more than 6 months post-MI, no recent angina or congestive heart failure: CHF exacerbations).
排除标准
- •Healthy Adult Population
- •Participants with any history of diabetes or impaired glucose tolerance.
- •Female participants who are pregnant or breastfeeding or planning to become pregnant.
- •Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months).
- •Participants with any prescribed medications at the time of inclusion that may interfere with carbohydrate metabolism and fluid balance, e.g., diuretics, cyclosporin, steroids or any other treatments that cannot be allowed in the study, in the opinion of the investigator.
- •Known sensitivity to the investigational product(s) and its ingredients.
- •Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
- •Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participant participation in the study in the opinion of the medically qualified investigator.
- •Participants are following prolonged fasting or intermittent fasting (e.g., fasting periods exceeding 12-16 hours regularly).
- •Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each).
- •Participants who have other severe, acute or chronic, medical condition(s) (e.g., CVD, renal disease, UTI), laboratory abnormality(ies), or history of gastrointestinal surgery(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study. Patients with T2DM
- •Females who are pregnant or breastfeeding, or planning to become pregnant.
- •Females in perimenopausal state (before becoming amenorrhoeic for at least 12 consecutive months).
- •Adults on prescribed medication at the time of inclusion that may interfere with carbohydrate metabolism, (other than metformin with or without sulfonyl ureas) and fluid balance, e.g. cyclosporin, or any other treatments that cannot be allowed in the study, in the opinion of the investigator.
- •Adults on prescribed medications at the time of inclusion like Steroids, SGLT2 inhibitors, GLP-1 agonists, diuretics, alpha-glucosidase inhibitor, and drugs that affect hydration status.
- •Known sensitivity to the investigational product(s) and its ingredients.
- •Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
- •Participants with clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participation of the participant in the study in the opinion of the medically qualified investigator.
- •Participants with following conditions will be excluded: o Known to have hepatic impairment.
- •Known cirrhosis or ALT/AST more than 3 times ULN.b o Type-1 diabetes mellitus or latent autoimmune diabetes in adults (LADA). o History of severe hypoglycemia or unawareness in the last 6 months.
- •Participants are following prolonged fasting or intermittent fasting (e.g., fasting periods exceeding 12-16 hours regularly).
- •Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each).
- •Participant who to have other severe, acute or chronic, medical condition(s) (eg. UTI), laboratory abnormality(ies), or history of gastrointestinal surgery(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study.
结局指标
主要结局
Healthy Adult Population
时间窗: Healthy Adult Population | Post 2 hours of beverage consumption. | Patients with T2DM | Post 2 hours of beverage consumption
Difference between the BHI of electrolyte beverage containing isomaltulose with that of the electrolyte beverage containing sucrose
时间窗: Healthy Adult Population | Post 2 hours of beverage consumption. | Patients with T2DM | Post 2 hours of beverage consumption
Patients with T2DM
时间窗: Healthy Adult Population | Post 2 hours of beverage consumption. | Patients with T2DM | Post 2 hours of beverage consumption
次要结局
- Healthy Adult Population and Patients with T2DM
研究者
Dr A G Unnikrishnan
Chellaram Diabetes Institute
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A study to see how a homoeopathic medicine bacillus morgan pure works in treating dermatitisCTRI/2025/09/095072Dr MPK Homoeopathy Medical College Hospital and Research Centre60
尚未招募
2 期
Comparing the effect of an oral ayurvedic medicine with and without ayurvedic powder massage in controlling high cholesterol.CTRI/2025/07/091626Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhyapradesh40
尚未招募
3 期
MANAGEMENT OF GRIDHRASI THROUGH SHEPHALIKA PATRA KASHAYAM AND RASNA GUGGULUCTRI/2025/11/096832Govt ayurveda college nipaniya rewa mp40
尚未招募
3 期
A clinical trial to study the effect of two drugs, Erandadi Kwatha and Simhasyadi Kwatha in the treatment of SciaticaCTRI/2025/01/078909kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobit University, Gangoh70
尚未招募
2 期
A Study of Ashwagandha Churna and Madanphaladi Pottali in the management of Garbhashaya Yoni BhramshaCTRI/2024/11/076497Post Graduate Department of Prasuti Tantra evam Stri Roga State Ayurvedic college and hospital40