NCT02813031

Brief Summary

Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable healthy-volunteers

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

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

June 17, 2016

Last Update Submit

June 21, 2016

Conditions

Healthy Volunteers

Keywords

functional meat productshypocaloric fatsdiglycerideobesity

Outcome Measures

Primary Outcomes (1)

  • Changes in waist circumference

    The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).

    Before and after 8 weeks

Secondary Outcomes (4)

  • Changes in lipid profile

    Before and after 8 weeks

  • Changes in fat depots

    Before and after 8 weeks

  • Changes in blood clotting and endothelial function

    Before and after 8 weeks

  • Product safety

    Before and after 8 weeks

Study Arms (2)

Functional meat products with healthy lipids from olive oil

EXPERIMENTAL

Healthy people consuming 300g/week of functional meat products with high diglyceride lipid from olive oil

Other: Functional meat products

Traditional meat products

PLACEBO COMPARATOR

Healthy people consuming the same amount of traditional meat products

Other: Traditional meat products

Interventions

Functional meat productsOTHER
Functional meat products with healthy lipids from olive oil
Traditional meat productsOTHER
Traditional meat products

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 - 65 years old.
  • BMI \>20\<27
  • Adequate education level and comprehension of the clinical study.
  • Willingness to participate in the study as a volunteer and to provide written consent.

You may not qualify if:

  • Diagnosis of Type I Diabetes .
  • BMI \>27
  • Dyslipidemia under pharmacological treatment.
  • High blood pressure.
  • Dementia, neurological disease or reduction of cognitive function.
  • Severe illness (hepatic disease, renal disease, etc.).
  • Refusal to consume the experimental or control meat products (e.g. Vegetarians)
  • Refusal to follow healthy eating guidelines.
  • Taking medications that could affect the lipid and glycemic profiles (statins, fibrate, diuretics, corticoids, anti-inflammatory, hypoglucemic or insulin) 30 days before the beginning of the study.
  • Taking medications or substances for weight loss management (15 days before the beginning of the study).
  • Consideration to follow a weight loss diet during the duration of the study.
  • Pregnancy or lactation.
  • High intake of alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMDEA-Food

Madrid, Madrid, 28049, Spain

Location

Related Publications (4)

  • Nagao T, Watanabe H, Goto N, Onizawa K, Taguchi H, Matsuo N, Yasukawa T, Tsushima R, Shimasaki H, Itakura H. Dietary diacylglycerol suppresses accumulation of body fat compared to triacylglycerol in men in a double-blind controlled trial. J Nutr. 2000 Apr;130(4):792-7. doi: 10.1093/jn/130.4.792.

    PMID: 10736331BACKGROUND

  • Pearson AM. (1997). Principles and applications in production of reduced and low fat products. In: Production and processing of healthy meat, poultry and fish products. Advances in meat research. Vol 11. Pearson AM, Dutson TR (Eds). Blackie Academic & Professional

    BACKGROUND

  • Rudkowska I, Roynette CE, Demonty I, Vanstone CA, Jew S, Jones PJ. Diacylglycerol: efficacy and mechanism of action of an anti-obesity agent. Obes Res. 2005 Nov;13(11):1864-76. doi: 10.1038/oby.2005.229.

    PMID: 16339116BACKGROUND

  • Saito S, Yamaguchi T, Shoji K, Hibi M, Sugita T, Takase H. Effect of low concentration of diacylglycerol on mildly postprandial hypertriglyceridemia. Atherosclerosis. 2010 Dec;213(2):539-44. doi: 10.1016/j.atherosclerosis.2010.07.062. Epub 2010 Aug 19.

    PMID: 20837352BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, Nutrition PhD in Medicine

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 24, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

ES(1)