Vitamin A Absorption From Cassava in Women (FL-80)
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Purpose
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin A Deficiency |
Other: Beta-Carotene bio-fortified cassava porridge without oil Other: Beta-Carotene bio-fortified cassava porridge with oil Other: White cassava porridge with retinyl palmitate reference dose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Vitamin A Equivalence of Carotenoids From Cassava in Women |
- Vitamin A equivalency from varieties of cassava with and without oil [ Time Frame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min ] [ Designated as safety issue: No ]Vitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.
| Enrollment: | 10 |
| Study Start Date: | June 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cassava Treatment 1
Single meal containing bio-fortified, high carotenoid cassava without oil.
|
Other: Beta-Carotene bio-fortified cassava porridge without oil
300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.
|
|
Experimental: Cassava Treatment 2
Single meal containing bio-fortified, high carotenoid cassava with oil.
|
Other: Beta-Carotene bio-fortified cassava porridge with oil
300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.
|
|
Active Comparator: Cassava Treatment 3
Single meal containing low carotenoid cassava with oil and retinyl palmitate.
|
Other: White cassava porridge with retinyl palmitate reference dose
300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.
|
Detailed Description:
We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- non-smoking
- BMI between 18-30
- total cholesterol concentrations between 90 and 225 mg/dL
- blood pressure under 140/90 mm Hg
- hemoglobin above 11.5 g/dL
- blood chemistries within the normal range
Exclusion Criteria:
- must not be pregnant or trying to get pregnant
- must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
- must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
- must not have blood chemistry or health history results consistent with acute cancer or heart disease
- no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
- must not be allergic to cassava, peanuts, or peanut oil
Contacts and Locations| United States, California | |
| Western Human Nutrition Center, University of California Davis | |
| Davis, California, United States, 95616 | |
| Principal Investigator: | Betty J Burri, PhD | WHNRC, ARS, University of California Davis |
More Information
No publications provided
| Responsible Party: | USDA, Western Human Nutrition Research Center |
| ClinicalTrials.gov Identifier: | NCT01381276 History of Changes |
| Other Study ID Numbers: | WHNRC 223773-1 |
| Study First Received: | June 22, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by USDA, Western Human Nutrition Research Center:
|
Vitamin A |
Additional relevant MeSH terms:
|
Vitamin A Deficiency Night Blindness Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases Carotenoids Retinol palmitate Vitamin A Vitamins |
Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013