Palmitoleic Isomer Study

NCT02311790 | Completed

• 1 other identifier: 11516
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in small quantities in foods, most notably in dairy products. Observational evidence suggests a positive association between trans-C16:1 and insulin sensitivity, and negative association with risk of developing type 2 diabetes mellitus \[1-3\]. Cis-palmitoleic acid (cis-C16:1) is found naturally in foods and is particularly high in macadamia nuts and oil extracted from the sea buckthorn plant. Animal models suggest that this palmitoleic acid isomer also improves insulin sensitivity and reduces metabolic dysfunction. This pilot dosing study is necessary to inform the design of a larger trial to test the hypothesis that both trans-C16:1 and cis-C16:1 improve insulin resistance but at different doses. Plasma phospholipid fatty acid profiles will be used as the primary outcome measure.

Conditions

Insulin Sensitivity

Keywords

cis-C16:1n7 supplement; trans-C16:1n7 supplement; palmitoleic acid supplement

Outcome Measures

Primary Outcomes (1)

• Plasma phospholipid fatty acid profiles -

  PLP FA profile determined by gas chromatography

  18 weeks

Secondary Outcomes (12)

• Plasma sphingolipid profiles -

  18 weeks

• CBC

  18 weeks

• Insulin

  18 weeks

• Clinical Chemistry Profile

  18 weeks

• HDL-cholesterol

  18 weeks

Study Arms (2)

Trans-C16:1 supplement

EXPERIMENTAL

Volunteers will take trans-C16:1 supplement for 3 weeks

Dietary Supplement: Trans-C16:1 supplement

Cis-C16:1 supplement

EXPERIMENTAL

Volunteers will take cis-C16:1 supplement for 3 weeks

Dietary Supplement: Cis-C16:1 supplement

Interventions

Trans-C16:1 supplement DIETARY_SUPPLEMENT

Each volunteer will consume 3 escalating doses (120 mg/day, 240 mg/day and 480 mg/day) of trans-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each \[9 weeks total\]

Trans-C16:1 supplement

Cis-C16:1 supplement DIETARY_SUPPLEMENT

Each volunteer will consume 3 escalating doses (380 mg/day, 760 mg/day and 1520 mg/day) of cis-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each \[9 weeks total\]

Cis-C16:1 supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 to ≤ 70 years
• BMI ≥ 25 kg/m2 ≤ 40 kg/m2
• Normotensive with or without medication
• Normal fasting plasma glucose levels (≤120 mg/dL)
• Normal kidney function as assessed by serum creatinine and blood urea nitrogen
• Normal liver function as assessed by serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase (ALP)
• Normal thyroid function defined as screening TSH within normal ranges, without or with medication for at least 6 months
• Normal gastrointestinal function

You may not qualify if:

• Use of supplements containing fish oil or other lipid supplements (e.g., flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation
• Greater than 2 servings/day combined of cheese, whole-fat milk or whole-fat yogurt
• Diagnosed diabetes mellitus Type I or Type II and/or taking glucose lowering medications (e.g., metformin, actos, januvia)
• Use of medication known to affect lipid metabolism (HMG-CoA reductase inhibitors (statins, red yeast rice), bile acid sequestrants, cholesterol absorption inhibitors (exetimibe \[Zetia\]), nicotinic acid agents, fibrates, probucol, anticoagulants, hormone therapy medications containing estrogen, anabolic steroids)
• Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, or symptomatic peripheral arterial disease), active cancer, end stage renal disease, dementia, severe chronic obstructive pulmonary disease, significant liver disease
• Pregnancy or breastfeeding
• Unwillingness to adhere to study protocol
• No Social Security number (for payment and IRS forms).

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Huang NK, Matthan NR, Galluccio JM, Shi P, Lichtenstein AH, Mozaffarian D. Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study. J Nutr. 2020 Jun 1;150(6):1388-1396. doi: 10.1093/jn/nxaa060.

  PMID: 32140719 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alice H Lichtenstein, D.Sc.

  Tufts University/Jean Mayer Human Nutrition Research Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: July 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)