NCT02907112

Brief Summary

Excessive meat consumption, particularly of red and processed meat, is associated with increased risk of developing a range of chronic diseases. Meat production also significantly contributes to the production of global greenhouse gasses (GHG). Given the predicted global increase in the human population, coupled with the rise in demand for meat within emerging economies, it has been suggested that strategies to alter dietary patterns and reduce meat intake should be devised. With the provision of appropriate non- or reduced-meat alternatives, this study aims to investigate whether free living subjects can significantly reduce their meat intake, and whether such dietary changes positively impact on a range of health measures

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

September 15, 2016

Last Update Submit

March 23, 2020

Conditions

Keywords

meat intakemeat analoguesLDL CholesterolHDL Cholesterol

Outcome Measures

Primary Outcomes (1)

  • Fasting Serum total cholesterol concentration

    Fasting Serum total cholesterol concentration

    Week 0, 4,10 and 16

Secondary Outcomes (13)

  • Fasting Serum LDL cholesterol concentration

    Week 0, 4,10 and 16

  • Fasting Serum HDL cholesterol concentration

    Week 0, 4,10 and 16

  • Fasting whole blood glucose concentration

    Week 0, 4,10 and 16

  • Fasting Serum Insulin concentration

    Week 0, 4,10 and 16

  • Resting, supine blood pressure

    Week 0, 4,10 and 16

  • +8 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Participants to continue on their habitual diet for 4 weeks

Meat Reduction

EXPERIMENTAL

Participants asked to reduce their red and processed meat intake by 50% for 12 weeks

Behavioral: Meat reduction

Interventions

Meat reductionBEHAVIORAL

Advice, Motivational material and food products provided to participants

Meat Reduction

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18 - 28 kg/m2 Healthy Females should be premenopausal Good spoken and written English Consume 4-5 portions of red and/or processed meat per week consumption of greater than 70g per day

You may not qualify if:

  • Smoking Chronic diseases Hypertension Pregnancy / Breast feeding Chronic medication use (excluding oral contraceptives) Participation in any other research study three months prior to the screening or during study duration Clinically significant findings at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Human Physiology Unit

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (1)

  • Simpson EJ , Clark M , Razak AA , Salter A . The impact of reduced red and processed meat consumption on cardiovascular risk factors; an intervention trial in healthy volunteers. Food Funct. 2019 Oct 16;10(10):6690-6698. doi: 10.1039/c9fo00758j.

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Andrew Salter, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations