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ADIS: Alkaline Diet for Insulin Sensitivity

Sponsor
Garvan Institute of Medical Research (Other)
Overall Status
Completed
CT.gov ID
NCT02501343
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
21.1
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
  • Drug: Sodium Bicarbonate Oral Capsule
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Alkaline Diet for Insulin Sensitivity
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in venous blood pH [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

    Secondary Outcome Measures

    1. Changes in glycemic response to the meal [Baseline (fasting) and 3 hours post meal]

      Postprandial glucose excursion will be compared between sodium bicarbonate and placebo

    2. Changes in insulin response to the meal [Baseline (fasting) and 3 hours post meal]

      Postprandial insulin excursion will be compared between sodium bicarbonate and placebo

    3. Changes in arterial stiffness [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

    4. Changes in hunger and satiety scores [Baseline (fasting) and 3 hours post meal]

      Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Garvan Institute of Medical Research Darlinghurst New South Wales Australia 2010

    Sponsors and Collaborators

    • Garvan Institute of Medical Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dorit Samocha-Bonet, Leader, Clinical Insulin Resistance Group, Diabetes and Metabolism Division, Garvan Institute of Medical Research
    ClinicalTrials.gov Identifier:
    NCT02501343
    Other Study ID Numbers:
    • ADIS (SVH 14/157)
    First Posted:
    Jul 17, 2015
    Last Update Posted:
    Mar 7, 2017
    Last Verified:
    Mar 1, 2017
    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
    Keywords provided by Dorit Samocha-Bonet, Leader, Clinical Insulin Resistance Group, Diabetes and Metabolism Division, Garvan Institute of Medical Research
    Glucose metabolism
    Potential renal acid load
    Postprandial glycemia
    Body acid-base homeostasis
    Sodium bicarbonate
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Insulin Resistance

    Study Results

    No Results Posted as of Mar 7, 2017