N/A N=39 Screening

Change of Fructose to Fat in South Asians

Elevated Triglycerides · Diabetes · Cardiovascular Disease · Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT01562782 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate — 1.24; 1.85 fold change — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fructose + Glucose Beverage (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: The Rogosin Institute
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate	1.24; 1.85	0.05
SECONDARY Fold Changes in VLDL Triglycerides in South Asians and Caucasians	1.05; 1.44	<0.05 sig
SECONDARY Peak Glucose Levels in 2 Study Groups	5.16; 5.61	<0.05 sig
SECONDARY Peak Insulin Levels in 2 Study Groups	93; 111	<0.05 sig
SECONDARY Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups	277; 274	<0.05 sig
SECONDARY Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism	0.1137; 0.0127; 0.3339; 0.3149; 0.2320; 0.0359	<0.05 sig
SECONDARY Fold Changes in Triglycerides in 2 Study Groups	1.05; 1.43	<0.05 sig
SECONDARY Peak Lactate Levels in 2 Study Groups	3.43; 3.91	<0.05 sig
SECONDARY Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups	0.09; 0.09	<0.05 sig
SECONDARY Peak Glucose in 2 Study Groups	5.16; 5.61	<0.05 sig

Summary

The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians).

Eligibility Criteria

Inclusion Criteria

Males and females, 18-35 years of age.
South Asian or Caucasian descent through self-identification (South Asians are to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh and no known non-South Asian ancestry in parents; Caucasians are to have both biological parents who self-identify as Caucasian and no known non-Caucasian ancestry in parents).
Body mass index (BMI) 18.0-24.9 kg/m2 with no history of obesity.
Fasting glucose 30 mg/dL, LDL cholesterol (LDL-C) 2 drinks/day) or illicit drugs.
History of severe psychiatric illness
If female, pregnant or breastfeeding
Participation in an investigational drug study within one month of screening.
Unusual diet or extreme level of physical activity
Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01562782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.