Postprandial Period Clinical Trial
Official title:
The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose, Insulin, and Gut Hormone Responses. The PEA-POD Study
Verified date | June 2019 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 29 |
Est. completion date | May 20, 2020 |
Est. primary completion date | February 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Metabolic Research Unit | London | Please Choose |
Lead Sponsor | Collaborator |
---|---|
King's College London | Biotechnology and Biological Sciences Research Council, New-Food Innovation, Quadram Institute Bioscience |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Postprandial Glycaemia (iAUC 0-60min) | The primary endpoint is iAUC 0-60 min for plasma glucose concentrations | 60 min | |
Primary | 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 | Phase 1: Postprandial Glycaemia (iAUC 0-120min) | iAUC 0-120 min for plasma glucose concentrations | 120 min | |
Secondary | Phase 1: Postprandial Glycaemia (iAUC 60-120min) | iAUC 60-120 min for plasma glucose concentrations | 60 min | |
Secondary | Phase 1: Postprandial Glycaemia (Cmax) | Cmax for plasma glucose concentrations | 120 min | |
Secondary | Phase 1: Postprandial Glycaemia (Tmax) | Tmax for plasma glucose concentrations | 120 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min) | iAUC 0-120 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 120 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-240min) | iAUC 0-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 240 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 30-90min) | iAUC 30-90 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 60 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 90-240min) | iAUC 90-240 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 150 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax) | Cmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 240 min | |
Secondary | Phase 2: Postprandial Glycaemia / Insulinaemia (Tmax) | Tmax for plasma glucose, Insulin, c-peptide and Gut hormone concentrations | 240 min |
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