- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06607354
Consuming Grass Finished Lamb Improves Blood Plasma ω-3 Fatty Acid Response Among Healthy Consumers.
September 20, 2024 updated by: Lynda Perkins, Queen's University, Belfast
The Effect of Consuming Grass Finished Lamb Meat on Omega-3 Blood Response Among Healthy Consumers
This study will investigate the impact of consuming grass-finished lamb meat on blood omega-3 PUFAs and cardiovascular risk factors compared to concentrate-finished lamb meat.
Healthy volunteers will consume three portions of lamb meat/week from a grass-finished meat treatment or a concentrate-finished meat treatment for four weeks.
Blood samples will be taken at weeks zero and four.
The primary outcome is to assess difference in change in omega-3 PUFA concentration in plasma and platelets between treatment groups.
The secondary outcome is to assess between groups differences in change in cardiovascular disease risk factors including blood pressure, BMI and lipids among healthy individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Belfast, United Kingdom, BT9 5DL
- School of Biological Sciences, Queen's University Belfast
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy male and female volunteers aged between 18-64 years old.
Exclusion Criteria:
- Participants with a BMI of <18.5 km/m² and greater than >35 km/m².
- Participants who take prescribed medication, including statins to reduce LDL cholesterol, and any form of dietary supplements (excluding vitamin D).
- People who smoke.
- Participants who consume more than two portions of fish per month.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Concentrate/ Cereal fed lamb
Participants to consume three portions of lamb per week for four consecutive weeks.
The lamb diet was a concentrate/cereal pellet.
|
|
|
Experimental: Grass fed lamb
Participants to consume three portions of lamb per week for four consecutive weeks.
The lamb diet was grass only.
|
This study investigated the impact of consuming grass finished lamb on total blood plasma and blood plasma phospholipids (PL) FA and on cardiovascular risk factors, including heart rate, blood pressure (BP), HDL-cholesterol, LDL-cholesterol, and TAG cholesterol, in humans.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatty acid (%) change in blood plasma between treatments
Time Frame: Week 0 and week 4
|
Primary outcome is to assess the impact of consuming grass vs concentrate finished lamb on blood plasma response in healthy volunteers
|
Week 0 and week 4
|
|
Fatty acid change (%) in blood plasma phospholipids between treatments
Time Frame: Week 0 and week 4
|
Primary outcome is to assess the impact of consuming grass vs concentrate finished lamb on blood plasma phospholipid response in healthy volunteers
|
Week 0 and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight (kg) in participants between treatments
Time Frame: Week 0 and week 4
|
Secondary outcome is to assess the impact of consuming grass vs concentrate finished lamb on weight among healthy volunteers
|
Week 0 and week 4
|
|
Change in Body Mass Index (BMI) in participants between treatments - calculated by dividing weight (kg) by height in meters squared
Time Frame: Week 0 and week 4
|
Secondary outcome is to assess the impact of consuming grass vs concentrate finished lamb on weight and BMI response in healthy volunteers
|
Week 0 and week 4
|
|
Cholesterol
Time Frame: Week 0 and week 4
|
Secondary outcome is to assess the impact of consuming grass vs concentrate finished lamb on total cholesterol, LDL, HDL and TAG response in healthy volunteers
|
Week 0 and week 4
|
|
Blood pressure (diastolic and systolic)
Time Frame: Week 0 and week 4
|
Secondary outcome is to assess the impact of consuming grass vs concentrate finished lamb on blood pressure (diastolic and systolic) response in healthy volunteers
|
Week 0 and week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jayne V Woodside, PhD, Queen's University, Belfast
- Principal Investigator: Nigel D Scollan, PhD, Queen's University, Belfast
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2019
Primary Completion (Actual)
December 13, 2019
Study Completion (Actual)
December 13, 2019
Study Registration Dates
First Submitted
September 9, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Actual)
September 24, 2024
Last Update Submitted That Met QC Criteria
September 20, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19.08v2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Grass fed lamb
-
Montana State UniversityOrganic Advisory and Education CouncilCompleted
-
Utah State UniversityDuke University; United States Department of Agriculture (USDA)Active, not recruiting
-
University of Missouri-ColumbiaRecruitingDiet InterventionUnited States
-
University of Auckland, New ZealandSingapore Institute for Clinical Sciences; Massey University; AgResearch; The Riddet...CompletedDiet, Healthy | Protein; DiseaseNew Zealand
-
Chinese PLA General HospitalCompletedCoronary Artery DiseaseChina
-
Rigshospitalet, DenmarkTRYG FoundationCompleted
-
Circassia LimitedWithdrawn
-
Allergy TherapeuticsCompletedType I HypersensitivityUnited States
-
ALK-Abelló A/SCompleted