Alkaline Diet for Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in venous blood pH
研究概览
简要总结
The purpose of this study is to test the effect of increasing the body pH acutely with an alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in non diabetic subjects with normal renal function.
The investigators aim to determine whether there is an acute reduction in venous blood pH following a typical Western-style (high acid load) breakfast in healthy men and women, and whether this effect is attenuated by the concurrent administration of an alkaline medication. The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be assessed.
详细描述
The aim of the study is to test the effect of increasing the body pH acutely with an alkali (NaHCO3) prior to a high acid load meal on glucose metabolism in non-diabetic men and women.
This is a double-blind placebo-controlled randomised study with a crossover design.
Study Procedures:
Two (2) meal studies will be performed 1 to 2 weeks apart. Studies will include collecting fasting blood to assess circulating glucose, insulin, C-peptide, free fatty acids, glucagon-like peptide-1, acid/base markers, including electrolytes (EUC) and venous blood pH. Participants will then be either administered sodibic (1680 mg) or matching placebo and a standardised Western style/high acid load meal. Investigators and participants will be blinded to the intervention. Blood will be drawn every 15 min in the first hour and then every 30 min for 3 hours in total. Arterial stiffness and appetite score will be evaluated at ½ h intervals.
Sample size: 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: 22-65
- •Disease status: Healthy.
- •Laboratory parameters: Fasting plasma glucose <7 mmol/L, HbA1c <6.5% (48 mmol/mol).
- •Willingness to give written informed consent and willingness to participate and comply with the study.
排除标准
- •Individuals with a personal history of diabetes, hypertension, cardiovascular disease, kidney disease, respiratory disease or inflammatory disease.
- •Individuals treated with medications known to affect insulin sensitivity.
- •Individuals with fasting plasma glucose ≥7 mmol/L, HbA1c ≥6.5% (48 mmol/mol).
- •Individuals with an unstable body weight in the past 3 months (+/- 2 kg or more).
- •Individuals with a history of a psychological illness or condition that may interfere with the participant's ability to understand the requirements of the study.
- •Individuals who smoke.
- •Individuals who consume more than 40 g of alcohol daily.
研究组 & 干预措施
Sodium bicarbonate
High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)
干预措施: Sodium Bicarbonate Oral Capsule (Drug)
Placebo
High acid load meal (Western style meal) with sodibic-matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in venous blood pH
时间窗: Baseline (fasting) and 3 hours post meal
The investigators aim is to determine whether venous blood pH decreases after a high acid load meal, and whether this effect is attenuated by administration of sodium bicarbonate prior to a mixed meal study
次要结局
- Changes in arterial stiffness(Baseline (fasting) and 3 hours post meal)
- Changes in glycemic response to the meal(Baseline (fasting) and 3 hours post meal)
- Changes in hunger and satiety scores(Baseline (fasting) and 3 hours post meal)
- Changes in insulin response to the meal(Baseline (fasting) and 3 hours post meal)
研究者
Dorit Samocha-Bonet
Leader, Clinical Insulin Resistance Group, Diabetes and Metabolism Division
Garvan Institute of Medical Research