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Completed

NCT Number: NCT03708939

Microbiome and Non-caloric Sweeteners in Humans

Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.

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Key information

Conditions

Glucose Intolerance Glucose Metabolism Disorders Glucose, High Blood Glucose, Low Blood Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weizmann Institute of Science

Rehovot, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI<28
  • Age - 18-70
  • Capable of working with smartphone application
  • Capable to work with a glucometer

Exclusion criteria

  • Consumption of antibitioics 3 months prior to the first day of the experiment.
  • Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
  • Diagnosis with type 1 or type 2 diabetes.
  • Pregnancy, fertility treatments
  • Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
  • Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
  • Cancer and recent anticancer treatment
  • Psychiatric disorders
  • Coagulation disorders
  • IBD (inflammatory bowel diseases)
  • Bariatric surgery
  • Alcohol or substance abuse
  • BMI>28
  • Aspartame group only: phenylketonuria.

Treatment and study plan

Glucose

Dietary Supplement

Daily consumption of 5g of glucose, for 14 days.

Aspartame

Dietary Supplement

Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.

Sucralose

Dietary Supplement

Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.

Saccharin

Dietary Supplement

Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.

Stevia

Dietary Supplement

Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.

No Supplement

Other

Follow up without any dietary supplementation.

Primary outcomes

  1. Blood glucose level

    Time frame: 28 days

    Continuous glucose monitor device

Secondary outcomes

  1. Microbiome

    Time frame: 28 days

    Stool and oral samples

Sponsors and collaborators

Lead sponsor

Weizmann Institute of Science

Other

Registry information

Official study title

The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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