Alkaline Diet for Insulin Sensitivity (ADIS)
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|ClinicalTrials.gov Identifier: NCT02501343|
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : March 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dysglycemia Type 2 Diabetes Mellitus||Drug: Sodium Bicarbonate Oral Capsule Drug: Placebo||Not Applicable|
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.
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
sample size calculation: To detect a difference in area under the curve (AUC) of venous blood pH with a paired crossover design, 32 individuals will be required with statistical power 1-β>0.8 (allowing for drop-out).
statistical considerations: Differences between AUC of outcome measures post sodium bicarbonate vs. placebo will be tested using paired t-tests. Two-way repeated measure ANOVA tests will be conducted to assess differences in the response to the meal with sodium bicarbonate vs. placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Alkaline Diet for Insulin Sensitivity|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Sodium bicarbonate
High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)
Drug: Sodium Bicarbonate Oral Capsule
Sodium bicarbonate 1680 mg will be administered prior to the meal
Other Name: Sodibic capsules (Aspen Australia, NSW, Australia)
Placebo Comparator: Placebo
High acid load meal (Western style meal) with sodibic-matching placebo
Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
- Changes in venous blood pH [ Time Frame: 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
- Changes in glycemic response to the meal [ Time Frame: Baseline (fasting) and 3 hours post meal ]Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
- Changes in insulin response to the meal [ Time Frame: Baseline (fasting) and 3 hours post meal ]Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
- Changes in arterial stiffness [ Time Frame: Baseline (fasting) and 3 hours post meal ]Postprandial arterial stiffness (measured by the augmentation index derived from Sphygmocore, Atcor Medical, Australia) will be compared between sodium bicarbonate and placebo
- Changes in hunger and satiety scores [ Time Frame: Baseline (fasting) and 3 hours post meal ]Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501343
|Australia, New South Wales|
|Garvan Institute of Medical Research|
|Darlinghurst, New South Wales, Australia, 2010|
|Principal Investigator:||Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD||Garvan Institute of Medical Research|