NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-AA-0047

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended
Gender: Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

White;
Native Hawaiian/Pacific Islander;
American Indian or Alaskan Native;
Asian;
Children;
Male

Keywords

Drug Metabolism;
Artificial Sweetener;
P-Glycoprotein;
Cytochrome P450;
Microbiome

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers;
Overweight

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Sucralose
Other: Placebo

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

INCLUSION CRITERIA:

1. Age: between 18 and 60 years

2. Female adults who self-identify as Hispanic and/or Black

3. Body weight greater than 50 kg (110 lb)

4. Body mass index between 25 kg/m^2 and 40 kg/m^2

5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent

6. Healthy with no known active medical condition or illness that requires drug treatment

7. Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for

4 weeks

8. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study

9. Able and willing to collect stool specimens

10. Able and willing to consume digoxin and midazolam during study visits

EXCLUSION CRITERIA:

1. 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.

2. Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)

3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics

4. GI history, at the discretion of the investigators

5. Known allergy, sensitivity, or other contraindication to study procedures

6. ALT or AST more than 1.5 times the upper limit of normal

7. Abnormal thyroid function or abnormal serum electrolytes & minerals (specifically potassium, calcium, and magnesium)

8. Narrow angle glaucoma or untreated open angle glaucoma

9. Regular use of alcohol (more than 1 drink per day) or drug use

10. History of cardiac abnormalities, especially arrhythmia

11. Unable or unwilling to cooperate with study procedures

12. 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

13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).


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Citations:

Abou-Donia MB, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS. Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats. J Toxicol Environ Health A. 2008;71(21):1415-29. doi: 10.1080/15287390802328630.

Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. eCollection 2016.

Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Paule V. Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5330
10 CENTER DR
BETHESDA MD 20892
(301) 827-5234
paule.joseph@nih.gov

Paule V. Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5330
10 CENTER DR
BETHESDA MD 20892
(301) 827-5234
paule.joseph@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03407079

--Back to Top--

NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-AA-0047

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended
Gender: Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

White;
Native Hawaiian/Pacific Islander;
American Indian or Alaskan Native;
Asian;
Children;
Male

Keywords

Drug Metabolism;
Artificial Sweetener;
P-Glycoprotein;
Cytochrome P450;
Microbiome

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers;
Overweight

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Sucralose
Other: Placebo

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

1. Age: between 18 and 60 years

2. Female adults who self-identify as Hispanic and/or Black

3. Body weight greater than 50 kg (110 lb)

4. Body mass index between 25 kg/m^2 and 40 kg/m^2

5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent

6. Healthy with no known active medical condition or illness that requires drug treatment

7. Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for

4 weeks

8. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study

9. Able and willing to collect stool specimens

10. Able and willing to consume digoxin and midazolam during study visits

EXCLUSION CRITERIA:

1. 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.

2. Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)

3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics

4. GI history, at the discretion of the investigators

5. Known allergy, sensitivity, or other contraindication to study procedures

6. ALT or AST more than 1.5 times the upper limit of normal

7. Abnormal thyroid function or abnormal serum electrolytes & minerals (specifically potassium, calcium, and magnesium)

8. Narrow angle glaucoma or untreated open angle glaucoma

9. Regular use of alcohol (more than 1 drink per day) or drug use

10. History of cardiac abnormalities, especially arrhythmia

11. Unable or unwilling to cooperate with study procedures

12. 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

13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).


--Back to Top--

Citations:

Abou-Donia MB, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS. Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats. J Toxicol Environ Health A. 2008;71(21):1415-29. doi: 10.1080/15287390802328630.

Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. eCollection 2016.

Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Paule V. Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5330
10 CENTER DR
BETHESDA MD 20892
(301) 827-5234
paule.joseph@nih.gov

Paule V. Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5330
10 CENTER DR
BETHESDA MD 20892
(301) 827-5234
paule.joseph@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03407079

--Back to Top--