The Effect of Dietary Sitosterol on Blood Sugar and Cholesterol

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00531128
• Date of registration: 14/09/2007
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: The Effect of Dietary Sitosterol on Blood Sugar and Cholesterol
• Scientific title: A Nutrigenomics Intervention for the Study of the Role of Dietary Sitosterol on Lipid, Glucose and Energy Metabolism
• Date of first enrolment: September 10, 2007
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00531128
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention.
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Kong Y Chen, Ph.D.
• Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

- Age greater than or equal to 18 years, male or female

- Genotype ABCG8: G574 (case) or R574 (control)

- Amish ethnicity (as self-described and from the Fisher's Book)

- Informed consent (obtained in the presence of the Amish Liaison nurse)

- Control person: same sex and age +/- 5 years from case

EXCLUSION CRITERIA:

- BMI greater than or equal to 40 kg/m(2)

- History or symptoms compatible with cardiovascular disease, including hypertension
greater than or equal to 140/90 mm Hg or current therapy for hypertension or
cardiovascular disease

- Allergy to lidocaine, acetaminophen with codeine, oxycodone.

- Pregnancy

- Breastfeeding

- Use of hormonal contraceptives or estrogen replacement therapy

- Diabetes mellitus, either type 1 or 2

- Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), and/or use of
antilipemic therapy

- Liver disease or ALT serum level greater than two fold the upper laboratory reference
limit

- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min

- Use of medications/dietary supplements/alternative therapies known or thought to alter
lipid or carbohydrate metabolism (e.g. omega-3 fatty acids, chromium, vanadate) during
the study

- Current history or symptoms compatible with psychosis including major depression
(including history of hospitalization for depression, history of attempted suicide,
history of suicidal ideation), and/or use of antipsychotic medications

- History of drug or alcohol abuse within the last 5 years; current use of drugs or
alcohol (CAGE greater than 3)

- Keloid formation (relative to subcutaneous adipose tissue biopsy)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sitosterolemia

Intervention(s)

Behavioral: High/Low Sitosterol

Primary Outcome(s)

Circulating lipids, glucose disposal, energy expenditure.

Secondary Outcome(s)

Endothelial vascular function, adipose tissue gene expression.

Secondary ID(s)

070219

07-DK-0219

Source(s) of Monetary Support

Please refer to primary and secondary sponsors