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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02501343




Registration number
NCT02501343
Ethics application status
Date submitted
13/07/2015
Date registered
17/07/2015
Date last updated
7/03/2017

Titles & IDs
Public title
Alkaline Diet for Insulin Sensitivity
Scientific title
Alkaline Diet for Insulin Sensitivity
Secondary ID [1] 0 0
ADIS (SVH 14/157)
Universal Trial Number (UTN)
Trial acronym
ADIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysglycemia 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sodium Bicarbonate Oral Capsule
Treatment: Drugs - Placebo

Experimental: Sodium bicarbonate - High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg*2)

Placebo Comparator: Placebo - High acid load meal (Western style meal) with sodibic-matching placebo


Treatment: Drugs: Sodium Bicarbonate Oral Capsule
Sodium bicarbonate 1680 mg will be administered prior to the meal

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in venous blood pH - 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
Timepoint [1] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [1] 0 0
Changes in glycemic response to the meal - Postprandial glucose excursion will be compared between sodium bicarbonate and placebo
Timepoint [1] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [2] 0 0
Changes in insulin response to the meal - Postprandial insulin excursion will be compared between sodium bicarbonate and placebo
Timepoint [2] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [3] 0 0
Changes in arterial stiffness - Postprandial arterial stiffness (measured by the augmentation index derived from Sphygmocore, Atcor Medical, Australia) will be compared between sodium bicarbonate and placebo
Timepoint [3] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [4] 0 0
Changes in hunger and satiety scores - Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo
Timepoint [4] 0 0
Baseline (fasting) and 3 hours post meal

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02501343
Trial related presentations / publications
DeFronzo RA, Beckles AD. Glucose intolerance following chronic metabolic acidosis in man. Am J Physiol. 1979 Apr;236(4):E328-34.
Fagherazzi G, Vilier A, Bonnet F, Lajous M, Balkau B, Boutron-Rualt MC, Clavel-Chapelon F. Dietary acid load and risk of type 2 diabetes: the E3N-EPIC cohort study. Diabetologia. 2014 Feb;57(2):313-20.
Reaich D, Graham KA, Channon SM, Hetherington C, Scrimgeour CM, Wilkinson R, Goodship TH. Insulin-mediated changes in PD and glucose uptake after correction of acidosis in humans with CRF. Am J Physiol. 1995 Jan;268(1 Pt 1):E121-6.
Souto G, Donapetry C, Calviño J, Adeva MM. Metabolic acidosis-induced insulin resistance and cardiovascular risk. Metab Syndr Relat Disord. 2011 Aug;9(4):247-53. doi: 10.1089/met.2010.0108. Epub 2011 Feb 25. Review.
Adeva MM, Souto G. Diet-induced metabolic acidosis. Clin Nutr. 2011 Aug;30(4):416-21. doi: 10.1016/j.clnu.2011.03.008. Epub 2011 Apr 9. Review.
Samocha-Bonet D, Campbell LV, Mori TA, Croft KD, Greenfield JR, Turner N, Heilbronn LK. Overfeeding reduces insulin sensitivity and increases oxidative stress, without altering markers of mitochondrial content and function in humans. PLoS One. 2012;7(5):e36320. doi: 10.1371/journal.pone.0036320. Epub 2012 May 7.
Farwell WR, Taylor EN. Serum bicarbonate, anion gap and insulin resistance in the National Health and Nutrition Examination Survey. Diabet Med. 2008 Jul;25(7):798-804. doi: 10.1111/j.1464-5491.2008.02471.x.
Mandel EI, Curhan GC, Hu FB, Taylor EN. Plasma bicarbonate and risk of type 2 diabetes mellitus. CMAJ. 2012 Sep 18;184(13):E719-25. doi: 10.1503/cmaj.120438. Epub 2012 Jul 23.
Crawford SO, Hoogeveen RC, Brancati FL, Astor BC, Ballantyne CM, Schmidt MI, Young JH. Association of blood lactate with type 2 diabetes: the Atherosclerosis Risk in Communities Carotid MRI Study. Int J Epidemiol. 2010 Dec;39(6):1647-55. doi: 10.1093/ije/dyq126. Epub 2010 Aug 25.
Lovejoy J, Newby FD, Gebhart SS, DiGirolamo M. Insulin resistance in obesity is associated with elevated basal lactate levels and diminished lactate appearance following intravenous glucose and insulin. Metabolism. 1992 Jan;41(1):22-7.
Hayata H, Miyazaki H, Niisato N, Yokoyama N, Marunaka Y. Lowered extracellular pH is involved in the pathogenesis of skeletal muscle insulin resistance. Biochem Biophys Res Commun. 2014 Feb 28;445(1):170-4. doi: 10.1016/j.bbrc.2014.01.162. Epub 2014 Feb 3.
Akter S, Eguchi M, Kurotani K, Kochi T, Pham NM, Ito R, Kuwahara K, Tsuruoka H, Mizoue T, Kabe I, Nanri A. High dietary acid load is associated with increased prevalence of hypertension: the Furukawa Nutrition and Health Study. Nutrition. 2015 Feb;31(2):298-303. doi: 10.1016/j.nut.2014.07.007. Epub 2014 Jul 30.
Juraschek SP, Selvin E, Miller ER, Brancati FL, Young JH. Plasma lactate and diabetes risk in 8045 participants of the atherosclerosis risk in communities study. Ann Epidemiol. 2013 Dec;23(12):791-796.e4. doi: 10.1016/j.annepidem.2013.09.005. Epub 2013 Oct 5.
Heilbronn LK, Gan SK, Turner N, Campbell LV, Chisholm DJ. Markers of mitochondrial biogenesis and metabolism are lower in overweight and obese insulin-resistant subjects. J Clin Endocrinol Metab. 2007 Apr;92(4):1467-73. Epub 2007 Jan 23.
Maalouf NM, Cameron MA, Moe OW, Adams-Huet B, Sakhaee K. Low urine pH: a novel feature of the metabolic syndrome. Clin J Am Soc Nephrol. 2007 Sep;2(5):883-8. Epub 2007 Aug 16.
Public notes

Contacts
Principal investigator
Name 0 0
Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications