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The Postprandial Effects of Chick-Pea Consumption on Glucose, Insulin, and Gut Hormone Responses (PEA-POD).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994276
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
Quadram Institute Bioscience
New-Food Innovation
Biotechnology and Biological Sciences Research Council
Information provided by (Responsible Party):
King's College London

Brief Summary:

Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage results in a loss of such properties and also the potential health benefits to consumers.

This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients. We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.

This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed at breakfast, as a drink and incorporated into a food matrix (bread).


Condition or disease Intervention/treatment Phase
Postprandial Period Dietary Supplement: Chickpea powder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over design: Each participant will receive a control plus 2 treatments
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose, Insulin, and Gut Hormone Responses. The PEA-POD Study
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : February 10, 2020
Estimated Study Completion Date : May 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Placebo Comparator: Phase 1: Control
oral glucose tolerance test (OGTT): 58g Dextrose in 330ml water
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).

Active Comparator: Phase1: Chickpea Control
"sub-cellular" Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).

Experimental: Phase1: Chickpea Powder
Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).

Active Comparator: Phase 2: Control
Wheat bread: breakfast consisting of a 100% wheat bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).

Experimental: Phase 2: 30%Chickpea Powder
Wheat bread: breakfast consisting of a 70% wheat / 30% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).

Experimental: Phase 2: 60%Chickpea Powder
Wheat bread: breakfast consisting of a 40% wheat / 60% Chickpea powder bread roll containing 54g available carbohydrate + 20g diabetic strawberry jam containing 2g sugar + 360ml water
Dietary Supplement: Chickpea powder
Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).




Primary Outcome Measures :
  1. Phase 1: Postprandial Glycaemia (iAUC 0-60min) [ Time Frame: 60 min ]
    The primary endpoint is iAUC 0-60 min for plasma glucose concentrations

  2. Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-60min) [ Time Frame: 60 min ]
    The primary endpoint is iAUC 0-60 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations


Secondary Outcome Measures :
  1. Phase 1: Postprandial Glycaemia (iAUC 0-120min) [ Time Frame: 120 min ]
    iAUC 0-120 min for plasma glucose concentrations

  2. Phase 1: Postprandial Glycaemia (iAUC 60-120min) [ Time Frame: 60 min ]
    iAUC 60-120 min for plasma glucose concentrations

  3. Phase 1: Postprandial Glycaemia (Cmax) [ Time Frame: 120 min ]
    Cmax for plasma glucose concentrations

  4. Phase 1: Postprandial Glycaemia (Tmax) [ Time Frame: 120 min ]
    Tmax for plasma glucose concentrations

  5. Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min) [ Time Frame: 120 min ]
    iAUC 0-120 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  6. Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-240min) [ Time Frame: 240 min ]
    iAUC 0-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  7. Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 30-90min) [ Time Frame: 60 min ]
    iAUC 30-90 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  8. Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 90-240min) [ Time Frame: 150 min ]
    iAUC 90-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  9. Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax) [ Time Frame: 240 min ]
    Cmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  10. Phase 2: Postprandial Glycaemia / Insulinaemia (Tmax) [ Time Frame: 240 min ]
    Tmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-45 y
  • Men and women
  • Healthy (free of diagnosed diseases listed in the exclusion criteria)
  • Body Mass Index 18-35 kg/m2
  • Able to understand the information sheet and willing to comply with study protocol
  • Able to give informed written consent

Exclusion Criteria:

  • Those with known or suspected food allergies (particularly to wheat, as specified in the screening questionnaire and participant information form) or hypersensitivity
  • Women who are pregnant, intending to become pregnant, or breastfeeding
  • Participation in another clinical trial
  • Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
  • Body mass index <18 or >35 kg/m2
  • Full Blood Counts and Liver Function test results outside of the normal range.
  • Current smokers, or reported giving up smoking within the last 6 months History of substance abuse or alcoholism
  • Reported history of Cardiovascular disease, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
  • Blood pressure ≥160/100 mmHg
  • Total cholesterol ≥ 7.8 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
  • Medications that may interfere with the study: alpha-glucosidase inhibitors (acarbose:

Glucobay), insulin- sensitising drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid- lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates).

Other medications should be reviewed by a medical representative from KCL on a case by case basis.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994276


Locations
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United Kingdom
Metabolic Research Unit
London, Please Choose, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Quadram Institute Bioscience
New-Food Innovation
Biotechnology and Biological Sciences Research Council
Investigators
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Principal Investigator: Peter Ellis, PhD King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03994276    
Other Study ID Numbers: HR-18/19-8431
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Chickpea
Cell Wall
Dietary Fibre
Postprandial
Metabolism
Enteroendocrine