NCT02228291

Brief Summary

This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects. Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable obesity

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

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

August 27, 2014

Last Update Submit

July 6, 2015

Conditions

ObesityOverweight

Keywords

PolyphenolsEndothelial functionGut barrier function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product.

    6 weeks

Secondary Outcomes (8)

  • Endothelial function

    6 weeks

  • Blood pressure & heart rate

    6 weeks

  • Glucose / insulin metabolism

    6 weeks

  • Lipid profile

    6 weeks

  • Gut barrier function

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Cellulose

Dietary Supplement: Placebo

Citric flavonoid

EXPERIMENTAL

Citric flavonoid

Dietary Supplement: Capsule containing citrus flavonoid

Interventions

Capsule containing citrus flavonoidDIETARY_SUPPLEMENT
Citric flavonoid
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight men/women (BMI 25-35 kg/m2)
  • Healthy individuals
  • Age between 18 and 70 years
  • Fasting glucose \< 7.0 mmol/L
  • Normal HbA1c (4.4 to 6.2%)

You may not qualify if:

  • Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
  • Gastroenterological diseases or abdominal surgery
  • Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
  • Self-admitted HIV-positive status
  • Abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs
  • Smoking
  • Plans to lose weight or following a hypocaloric diet during the study period
  • Weight gain or loss \> 3 kg in previous 3 months
  • Use of medication interfering with endpoints
  • Intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin are strictly forbidden
  • Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
  • Hormone replacement therapy (women)
  • Use of antibiotics in the 90 days prior to the start of study
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
  • Known pregnancy (assessed by a pregnancy test before start of study), lactation
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

  • Salden BN, Troost FJ, de Groot E, Stevens YR, Garces-Rimon M, Possemiers S, Winkens B, Masclee AA. Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals. Am J Clin Nutr. 2016 Dec;104(6):1523-1533. doi: 10.3945/ajcn.116.136960. Epub 2016 Oct 26.

    PMID: 27797708DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • A.A.M. Masclee, MD, PhD

    Department of Internal Medicine, Division of Gastroenterology-Hepatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

NL(1)