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

NCT02312492 | Completed

• 1 other identifier: 1542 - Fatty Acid Kinetics
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Dyslipidemia

Keywords

fatty acid kinetics

Outcome Measures

Primary Outcomes (11)

• fatty acid kinetics in total plasma

  measurement of isotope ratio (13C:12C) in total plasma, cholesterol ester, triglyceride, phospholipid, monoglyceride and diglyceride subfractions as well as chylomicrons, VLDL (very low density lipoprotein), TRL (triglyceride-rich lipoprotein), LDL (low density lipoprotein) and HDL (high density lipoprotein).

  15 weeks

• fatty acid kinetics in cholesterol ester

  15 weeks

• fatty acid kinetics in triglyceride

  15 weeks

• fatty acid kinetics in phospholipid

  15 weeks

• fatty acid kinetics in monoglyceride subfraction

  15 weeks

• fatty acid kinetics in diglyceride subfraction

  15 weeks

• fatty acid kinetics in chylomicrons

  15 weeks

• fatty acid kinetics in VLDL (very low density lipoprotein)

  15 weeks

• fatty acid kinetics in TRL (triglyceride-rich lipoprotein)

  15 weeks

• fatty acid kinetics in LDL (low density lipoprotein)

  15 weeks

• fatty acid kinetics in HDL (high density lipoprotein)

  15 weeks

Secondary Outcomes (1)

• rate of oxidation

  15 weeks

Study Arms (3)

18:1 diet

EXPERIMENTAL

Oleic Diet - volunteers will consume oleic enriched food for a period of 5 weeks.

Other: Oleic Diet

16:0 diet

EXPERIMENTAL

Palmitic diet - Volunteers will consume palmitic enriched food for a period of 5 weeks.

Other: Palmitic Diet

18:0

EXPERIMENTAL

Stearic Diet - Volunteers will receive Stearic enriched food for a period of 5 weeks.

Other: Stearic Diet

Interventions

Oleic Diet OTHER

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.

Also known as: Diet enriched in oleic acid, 18:1

18:1 diet

Palmitic Diet OTHER

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.

Also known as: Diet enriched in palmitic acid., 16:0

16:0 diet

Stearic Diet OTHER

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.

Also known as: Stearic acid enriched diet., 18:0

18:0

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (menopause defined by complete natural cessation of menses for \>12 months or a bilateral oophorectomy).
• Age \>50 to \< 85 years
• BMI \>20 to \<35 kg/m2
• LDL-cholesterol \>100 mg/dL
• CRP (C reactive protein) \<10 ug/dL
• Normal fasting plasma glucose levels (\<120 mg/dL)
• Not taking medication known to affect lipid metabolism:
• HMG-CoA reductase inhibitors (statins)
• Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
• Cholesterol Absorption Inhibitors (Ezetimibe \[Zetia\])
• Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
• Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate \[Tricor\], etc)
• Probucol
• Anticoagulants (Coumadin, Heparin, Plavix, etc)
• Hormone therapy medications containing estrogen

You may not qualify if:

• Men
• Women who have had a double mastectomy
• Age \< 50 and \> 85 years
• BMI \< 20 and \> 35 kg/m2
• LDL-cholesterol \<100 mg/dL
• CRP \> 10 ug/dL
• Abnormal fasting plasma glucose levels \>120 mg/dL
• Use of medications known to affect lipid metabolism:
• HMG-CoA reductase inhibitors (statins)
• Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
• Cholesterol Absorption Inhibitors (Ezetimibe \[Zetia\])
• Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
• Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate \[Tricor\], etc)
• Anticoagulants (Coumadin, Heparin, Plavix, etc)
• Hormone therapy medications containing estrogen

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Oleic Acid; Palmitic Acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oleic Acids; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Palmitic Acids

Study Officials

• Alice H Lichtenstein, D.Sc.

  Tufts University/HNRCA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: December 9, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)