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

NCT03994276 | Completed

• 1 other identifier: HR-18/19-8431
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Postprandial Period

Keywords

Chickpea; Cell Wall; Dietary Fibre; Postprandial; Metabolism; Enteroendocrine

Outcome Measures

Primary Outcomes (2)

• Phase 1: Postprandial Glycaemia (iAUC 0-60min)

  The primary endpoint is iAUC 0-60 min for plasma glucose concentrations

  60 min

• Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-60min)

  The primary endpoint is iAUC 0-60 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

  60 min

Secondary Outcomes (10)

• Phase 1: Postprandial Glycaemia (iAUC 0-120min)

  120 min

• Phase 1: Postprandial Glycaemia (iAUC 60-120min)

  60 min

• Phase 1: Postprandial Glycaemia (Cmax)

  120 min

• Phase 1: Postprandial Glycaemia (Tmax)

  120 min

• Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min)

  120 min

Study Arms (6)

Phase 1: Control

PLACEBO COMPARATOR

oral glucose tolerance test (OGTT): 58g Dextrose in 330ml water

Dietary Supplement: Chickpea powder

Phase1: Chickpea Control

ACTIVE COMPARATOR

"sub-cellular" Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring

Dietary Supplement: Chickpea powder

Phase1: Chickpea Powder

EXPERIMENTAL

Chickpea powder: 58g total available carbohydrate, provided as 50g from chickpea powder + 8g from chocolate flavouring

Dietary Supplement: Chickpea powder

Phase 2: Control

ACTIVE COMPARATOR

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

Phase 2: 30%Chickpea Powder

EXPERIMENTAL

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

Phase 2: 60%Chickpea Powder

EXPERIMENTAL

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

Interventions

Chickpea powder DIETARY_SUPPLEMENT

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).

Phase 1: Control; Phase 2: 30%Chickpea Powder; Phase 2: 60%Chickpea Powder; Phase 2: Control; Phase1: Chickpea Control; Phase1: Chickpea Powder

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-45 y
• Men and women

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• King's College London: lead
• Quadram Institute Bioscience: collaborator
• New-Food Innovation: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

Metabolic Research Unit

London, Please Choose, SE1 9NH, United Kingdom

Location

Related Publications (1)

• Bajka BH, Pinto AM, Perez-Moral N, Saha S, Ryden P, Ahn-Jarvis J, van der Schoot A, Bland C, Berry SE, Ellis PR, Edwards CH. Enhanced secretion of satiety-promoting gut hormones in healthy humans after consumption of white bread enriched with cellular chickpea flour: A randomized crossover study. Am J Clin Nutr. 2023 Mar;117(3):477-489. doi: 10.1016/j.ajcnut.2022.12.008. Epub 2022 Dec 28.

  PMID: 36811474 DERIVED

Study Officials

• Peter Ellis, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over design: Each participant will receive a control plus 2 treatments

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: June 25, 2019
• Primary Completion: February 10, 2020
• Study Completion: May 20, 2020
• Last Updated: September 2, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)