Alkaline Diet for Insulin Sensitivity (ADIS)

March 5, 2017 updated by: Dorit Samocha-Bonet, Garvan Institute of Medical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Garvan Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Sodibic capsules (Aspen Australia, NSW, Australia)
PLACEBO_COMPARATOR: Placebo
High acid load meal (Western style meal) with sodibic-matching placebo
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (fasting) and 3 hours post meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (fasting) and 3 hours post meal
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
Baseline (fasting) and 3 hours post meal
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
Baseline (fasting) and 3 hours post meal
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
Baseline (fasting) and 3 hours post meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Garvan Institute of Medical Research

Investigators

  • Principal Investigator: Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD, Garvan Institute of Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (ESTIMATE)

July 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADIS (SVH 14/157)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Sodium Bicarbonate Oral Capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe