Influence of the Background Diet on Metabolism of Land-based n-3 PUFA

NCT03558776 | Completed

• 1 other identifier: H6_18
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

KoALA study - assessment of the influence of the background diet on the metabolism and the bioavailability of plant n-3 PUFA from linseed oil. In particular, the study design focusses on the impact of variations in the background diet as confounding factor (e.g. variations in concurrently intake of linoleic acid (n-6)). Further, the influence of a regular intake of milk fat, in particular from free-grazing ruminants, on n-3 PUFA metabolism will be investigated.

Conditions

Endogenous Conversion of Alpha Linolenic Acid

Keywords

alpha linolenic acid, linseed oil, eicosapentaenoic acid, docosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

• Percentage of EPA and further n-3 PUFA in plasma and erythrocyte lipids

  Percentage of EPA and further n-3 PUFA (ALA, DPA, DHA) in plasma and erythrocyte lipids (available from the gas chromatographic analysis)

  change from baseline after 4, 8 and 12 weeks

Secondary Outcomes (10)

• Fatty acid distribution in plasma lipids

  change from baseline after 4, 8 and 12 weeks

• Fatty acid distribution in erythrocyte lipids

  change from baseline after 4, 8 and 12 weeks

• Anthropometric and physiological data

  change from baseline after 4, 8 and 12 weeks

• Blood lipids

  change from baseline after 4, 8 and 12 weeks

• Inflammatory markers

  change from baseline after 4, 8 and 12 weeks

Study Arms (4)

Linseed oil plus defined background diet (high linolec acid)

ACTIVE COMPARATOR

Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: A) 7 ± 2 En% linoleic acid (n = 37)

Dietary Supplement: linseed oil

Linseed oil plus defined background diet (low linolec acid)

ACTIVE COMPARATOR

Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: B) \< 2.5 En% linoleic acid (n = 37)

Dietary Supplement: linseed oil

Linseed oil plus defined background diet (high milk)

ACTIVE COMPARATOR

Linseed oil (LO) plus daily menu plans (total dietary fat intake: 30 En%): 10 En% LO plus menu plan with 20 En% fat: C) 15 ± 2 En% milk fat (n = 37)

Dietary Supplement: linseed oil

Linseed oil without defined background diet

PLACEBO COMPARATOR

Linseed oil (LO) without defined menu plans (D) Western diet, n = 37)

Dietary Supplement: linseed oil

Interventions

linseed oil DIETARY_SUPPLEMENT

linseed oil and defined background diet

Linseed oil plus defined background diet (high linolec acid); Linseed oil plus defined background diet (high milk); Linseed oil plus defined background diet (low linolec acid); Linseed oil without defined background diet

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: 50 % male, 50 % female (in the menopause)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females (in the menopause) and males (50 % each); age: 40 - 65 years; BMI \< 30 kg/m2
• Subjects must be able and willing to give written informed consent, and to comply with study procedures
• Subjects with moderate elevated LDL cholesterol (\> 3 mmol/l), without lipid-lowering medication
• Persons who consume a traditional "Western diet" composed of meat, sausage, dairy products, cereals, vegetables, fruits etc.
• Precondition: stable eating habits at least one year before enrollment
• Subjects must have adequate fluency in the German language to complete the questionnaires and understand the daily menu plans
• No antihypertensive medication or stable dose for \>3 months prior to start of the study and during the entire study period

You may not qualify if:

• Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabe-tes mellitus (type I and II), chronic renal disease, diseases of the parathyroids, diseases necessitat-ing regular phlebotomies other chronic diseases which could affect the results of the present study
• Use of medication which could affect the results of the present study including systemic glucocorti-coids, lipid-lowering medication
• Hormone replacement therapy
• Use of dietary supplements, incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period)
• Weight loss or weight gain (\> 3 kg) during the last three months before study begin
• Relevant food allergies (e.g. milk, nuts etc.)
• Pregnancy or lactation
• Transfusion of blood in the last three months before blood sample taking

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader of the Junior Research Group Nutritional Concepts

Model Details: Blood samples will be taken at the beginning and regularly every four weeks during the 12-weeks intervention period. For all groups, the consumption of additional n-3 PUFA sources is not permitted during the entire intervention period. The study intervention will consist of a daily dose of linseed oil (LO, 10 En%) and prepared daily menu plans determining the background diet, except for the control group D. The fat composition of the developed daily menu plans (fat content 20 En%) will differ between the groups A to C. For groups A to C, the daily menu plans will ensure an adequate intake of energy and nutrients according to the guidelines of the German Society of Nutrition. Group D serves as control because in this group the background diet is not fixed by menu plans. Participants of group D must follow their normal dietary habits, i.e. a typical Western diet (LA intake is about 15 g/d (5-7 En%) / SFA intake ranges from 10 to 15 En%).

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: March 13, 2018
• Primary Completion: July 22, 2018
• Study Completion: December 31, 2018
• Last Updated: March 7, 2019

Record last verified: 2018-06

Locations

DE (1)