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OpenTrials
Completed

NCT Number: NCT03032640

Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors

The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to provide written informed consent
  • Age 18-45 years
  • Weight stable (± 3 kg) during the 6 months prior to enrollment
  • BMI ≤ 25 kg/m2
  • Consumption of less than a can of diet beverage or a spoonful of NCASs weekly (or each equivalent from foods) during the past month

Exclusion criteria

  • Known coronary artery disease, angina or congestive heart failure
  • Type 1 or Type 2 Diabetes (A1c ≥6.5%)
  • Bleeding disorders
  • Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
  • Acute or chronic infections
  • Hepatitis and/or cirrhosis
  • Severe asthma or chronic obstructive pulmonary disease
  • Renal insufficiency or nephritis (creatinine > 1.6 mg/dl)
  • Prior bariatric surgery
  • Inflammatory bowel disease or malabsorption
  • Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
  • Psychiatric disorders or eating disorders
  • Cushing's disease or syndrome
  • Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
  • Active rheumatoid arthritis or other inflammatory rheumatic disorder
  • Pregnant or nursing women
  • Smoking (smoking within the past 3 months)
  • Less than 4 bowel movements per week
  • Known hypersensitivity to saccharin, lactisole or any of its excipients.

Excluded medications include but are not limited to:

  • Anti-diabetic agents
  • Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
  • Antibiotic use (within the past 3 months)
  • Other drugs known to affect immune or metabolic function
  • Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)

Treatment and study plan

oral glucose tolerance test (OGTT)

Other

Once we test the fasting plasma glucose (after an overnight fast), subject will receive a 75g glucose beverage they will have to drink within 5 minutes. Then after drinking the beverage, 8 blood samples will be collected through the IV catheter, over the next 3 hours.

Assessment of dietary compliance

Other

Assessment of consumption of non-caloric artificial sweeteners

Stool sampling

Other

Subjects will provide a stool sample.

Sodium Saccharin

Other

Subjects in group 1 and group 3 will be provided with sodium saccharin.

Placebo

Other

Subjects in group 2 will be provided with placebo.

Lactisole

Other

Subjects in group 3 and group 4 will be provided with lactisole.

Primary outcomes

  1. Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.

    Time frame: 6 weeks

Secondary outcomes

  1. Short chain fatty acid analyses

    Time frame: 6 weeks

    Stool sample aliquoted and frozen by way of ribosomal sequencing, which will be used to determine what bacteria is in the fecal sample.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Acronym: ISTAR-micro

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Jan 26, 2017
Registry last updated
Feb 2, 2023

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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