What this study is
Background:
Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.
Objective:
To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.
Eligibility:
People ages 18-60 who:
- Are black or Hispanic
- Weigh more than 110 pounds
- Have a body mass index of 25-40
- Do not have a condition that requires drug treatment
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, heart, and urine tests
Participants must not eat or drink anything with artificial sweeteners throughout the study.
Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.
Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:
- An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.
- A piece of fat tissue may be taken from the abdomen (biopsy).
- Participants will have a sweet drink. Blood samples will be taken over 2 hours.
Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.
Overnight Visit 2 repeats Visit 1 except the biopsy.
Then participants will take the capsules for another 2 weeks.
Overnight Visit 3 repeats Visit 1.
Participants may be contacted by phone within 4 weeks after they finish.
What's being tested
- Sucralose
Intervention · OTHER
Sucralose is an organochlorine and is approximately 600 times sweeter than sucrose. Participants will receive sucralose (approximately 4mg/kg/day) or placebo by mouth in a capsule for 28 days. This dose corresponds to the amount of sucralose contained in approximately 3 or 4 twelve ounce cans of commercially-available diet soda for a 70 kg adult.
- Placebo
Intervention · OTHER
Placebo capsules will be taken orally for 28 days
Study details
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Conditions
- Healthy Volunteers · Overweight
- Enrolling
- 150 people
- Starts
- 2018-04-05
- Est. completion
- 2027-12-26
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- Age: between 18 and 60 years
- Female adults who self-identify as Hispanic and/or Black
- Body weight greater than 50 kg (110 lb)
- Body mass index between 25 kg/m^2 and 40 kg/m^2
- Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent
- Healthy with no known active medical condition or illness that requires drug treatment
- Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for 4 weeks
- Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study
- Able and willing to collect stool specimens
- Able and willing to consume digoxin and midazolam during study visits
You can't join if
- Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators.
- Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)
- Taken medications that affect blood sugar in the past 3 months or that include antibiotics
- GI history, at the discretion of the investigators
- Known allergy, sensitivity, or other contraindication to study procedures
- ALT or AST more than 1.5 times the upper limit of normal
- Abnormal thyroid function or abnormal serum electrolytes & minerals (specifically potassium, calcium, and magnesium)
- Narrow angle glaucoma or untreated open angle glaucoma
- Regular use of alcohol (more than 1 drink per day) or drug use
- History of cardiac abnormalities, especially arrhythmia
- Unable or unwilling to cooperate with study procedures
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures
- Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ID 180047
Principal investigator
Paule V Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.