Clinical trial NCT03424187: The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
Official title: The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.

Detailed description: Rationale:

There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.

To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:

Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

All of which will contain the same macro and micro nutrients from the same food sources

Eligibility criteria: Inclusion Criteria:

* Gender: male and female
* Age ≥ 18 years ≤ 65 years
* Normal weight as classified by BMI 20-29.9 kg/m2
* Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
* Willingness and ability to understand, participate and to comply with the study requirements
* Willingness and ability to give written informed consent

Exclusion Criteria:

* Has thyroid defects
* Under hormone or steroids therapy
* Is pregnant or lactating (female)
* Had given birth within the past year (female)
* Is taking drugs that could affect appetite or plasma glucose levels.
* Is taking natural remedies that modulate appetite or plasma glucose levels.
* Has excessive alcohol intake
* Had blood donation within 12wks prior to start date
* Psychiatric illness
* Smokers
* History of any disease with unknown outcome
* Has diabetes
* Has nut allergy

Primary outcomes:
measure: Post-prandial Glucose Concentrations
timeFrame: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
measure: Post-prandial Blood Insulin Concentrations
timeFrame: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
Secondary outcomes:
measure: Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
timeFrame: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
measure: Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
timeFrame: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
measure: Energy Intake at a Meal Given in Excess
timeFrame: post consumption of the test meal at 120 minutes
Other outcomes:
Locations:
Study officials:
References: