Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans

NCT02312492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-04-18

No results posted yet for this study

Summary

Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enriched in the corresponding fatty acid.

Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be characterized by similar transport, higher conversion, and similar oxidation rates..

Conditions

Interventions

OTHER

Oleic Diet

The 18:1 (oleic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (oleic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.

OTHER

Palmitic Diet

The 16:0 (palmitic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (palmitic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.

OTHER

Stearic Diet

The 18:0 diet (stearic) will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oil (stearic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Alice H Lichtenstein, D.Sc. · Tufts University/HNRCA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-06-30
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02312492 on ClinicalTrials.gov