The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses

NCT ID: NCT03424187

Last Updated: 2021-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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whole chickpea

a test meal containing 26g available carbohydrates from chickpea (full structure)

Group Type EXPERIMENTAL

chickpea

Intervention Type DIETARY_SUPPLEMENT

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

flour chickpea

a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)

Group Type EXPERIMENTAL

chickpea

Intervention Type DIETARY_SUPPLEMENT

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

intact cell chickpea

a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)

Group Type EXPERIMENTAL

chickpea

Intervention Type DIETARY_SUPPLEMENT

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

Interventions

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chickpea

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10.

Reference Type DERIVED
PMID: 38823849 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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15HH3069

Identifier Type: -

Identifier Source: org_study_id

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