NCT03531398

Brief Summary

The aim of the current study is to investigate the postprandial metabolic response to typically consumed fat and carbohydrate doses in single meals. An additional aim is to validate the use of dry blood spot (DBS) for triglyceride analysis versus venous blood sampling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 18, 2020

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

April 24, 2018

Last Update Submit

February 17, 2020

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

  • Postprandial lipaemia

    Change in serum triglycerides

    0-4 hours postprandially

Secondary Outcomes (1)

  • Postprandial glycaemia

    0-4 hours postprandially

Other Outcomes (2)

  • Postprandial plasma insulin

    0-4 hours postprandially

  • Postprandial plasma c-peptide

    0-4 hours postprandially

Study Arms (2)

High fat meal

EXPERIMENTAL

Muffin containing 30g fat

Other: Metabolic test meal challenge

Medium fat meal

EXPERIMENTAL

Muffin containing 20g fat

Other: Metabolic test meal challenge

Interventions

Metabolic test meal challengeOTHER

Metabolic test meal challenge

High fat mealMedium fat meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself identification from a questionnaire if male or female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-65 years.

You may not qualify if:

  • Able to understand the information sheet and willing to comply with study protocol.
  • Able to give informed consent.
  • Refuse or are unable to give informed consent to participate in the study
  • BMI \>32 kg/m2
  • BP \>170/100 mm Hg
  • Have had long term inflammatory disease or cancer in the last three years.
  • Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy).
  • Are taking the following daily medications: immunosuppressants, antibiotics in the last three months
  • Are long-term users of PPIs, unless they are able to stop two weeks before the start of the study.
  • Have type I diabetes mellitus or type II diabetes mellitus.
  • Are currently suffering from acute clinically diagnosed depression.
  • Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
  • Are pregnant
  • Are vegan, suffering from an eating disorder or unwilling to take foods that are part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, UK, SE1 9NH, United Kingdom

Location

Study Officials

  • Sarah Berry, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 21, 2018

Study Start

April 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 18, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)