Health Impacts of Sustainable Ingredient Selection in the Food and Drink Industry - ALTERNATIVE PROTEIN STUDY

NCT01898351 | Completed

• 1 other identifier: Alternative Protein Study 791
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Summary This research will examine the nutritional effects of supplementing diets with alternative plant sources of protein with potential to be grown in Scotland. In particular, we will assess the potential of these plant protein sources to complement diets in which the predominant source of protein is meat. These protein sources will include plants from the Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the development of new foods. The research will assess if these plant proteins can deliver a comparable alternative to meat based diets. It is anticipated that the results could encourage increased consumption of plant products which would be favorable for consumers shifting away from animal-derived proteins for health and/or environmental reasons. Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for partial replacement in predominantly meat based diets. Objective: The objective of this acute study is to assess satiety, postprandial effects, metabolite bioavailability and metabolism of single alternative proteins from a shortlist including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat. Study protocol Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with meat in healthy people on:

• Biomarkers of satiety as measured by gut-related hormones and subjective appetite using visual analogue scales, specifically to be collected during the meal over a three hour period, every 30 minutes. The energy intake measured for each volunteer after an ad libitum lunch (five hours after test meal).
• Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA).
• Assessment of peripheral glycaemic control, fasting glucose, area under the curve combined with insulin data.
• Plasma and urine markers of important phytochemical and protein metabolites will be quantitatively analysed to determine the systemic availability, in vivo concentrations and excretion times.
• Volunteer views towards diets rich in plant proteins will be assessed.

Conditions

Healthy

Keywords

Alternative sources of plant proteins; High protein diets; Satiety; Postprandial effects; Bioactive phytochemicals; Phytochemicals bioactivity and metabolism; Macronutrients metabolism; Health effects of plant proteins vs. meat proteins; Partial meat proteins replacement with plant proteins; Satiety of meals rich in plant proteins; Postprandial effects of meals rich in plant proteins; Plant phytochemicals and macronutrients bioavailability and metabolism

Outcome Measures

Primary Outcomes (1)

• Postprandial effects (including satiety )of a pea, fava bean, lupin, hemp, buckwheat in comparison with meat in healthy people.

  Each intervention visit will involve a test meal to be consumed by subjects attending the Human Nutrition Unit (HNU) in the morning, following an overnight fast. They will be provided with a meal, which will be consumed within 15 minutes and blood (69 mL) and urine samples will be collected during 24 hours . Biomarkers of satiety as measured by gut-related hormones and subjective appetite using visual analogue scales, specifically to be collected during the meal over a three hour period, every 30 minutes. The energy intake measured for each volunteer after an ad libitum lunch (five hours after test meal). Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA). Assessment of peripheral glycaemic control, fasting glucose, area under the curve combined with insulin data.

  up to 3 months

Secondary Outcomes (1)

• Metabolite bioavailability and metabolism of single alternative proteins from a shortlist including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat.

  up to 3 months

Other Outcomes (1)

• Volunteer views towards diets rich in plant proteins will be assessed.

  The assesment will take place during one of the interventtion visits of the study and will be around one hour long.

Study Arms (1)

Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat

OTHER

The intervention visit involves a test meal to be consumed by subjects attending the Human Nutrition Unit in the morning, following an overnight fast. The meal will be consumed within 15 minutes and blood (69 mL) and urine samples will be collected during 24 hours. The test meals are designed to contain the same amount of proteins. Alternative protein meals: a number of bread buns for each meal containing individual alternative protein flours (green pea, lupin, hemp, buckwheat, fava beans). These will deliver 30 g of protein, the remainder being provided by white flour. The control (meat) meal: a lean beef steak containing 30 g of protein and a bun containing the same amount of white flour as used for the alternative protein bread buns. The semi structured interview guide: will take place within the Human Nutrition Unit during one of the scheduled visits, once initial screening has taken place and participants have been selected. All interviews will be digitally recorded.

Other: Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat

Interventions

Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat OTHER

The intervention visit involves a test meal to be consumed by subjects attending the Human Nutrition Unit in the morning, following an overnight fast. The meal will be consumed within 15 minutes and blood (69 mL) and urine samples will be collected during 24 hours. The test meals are designed to contain the same amount of proteins. Alternative protein meals: a number of bread buns for each meal containing individual alternative protein flours (green pea, lupin, hemp, buckwheat, fava beans). These will deliver 30 g of protein, the remainder being provided by white flour. The control (meat) meal: a lean beef steak containing 30 g of protein and a bun containing the same amount of white flour as used for the alternative protein bread buns. The semi structured interview guide: will take place within the Human Nutrition Unit during one of the scheduled visits, once initial screening has taken place and participants have been selected. All interviews will be digitally recorded.

Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Diabetes Severe gastrointestinal disorders Kidney disease Thromboembolic or coagulation disease Hepatic disease Alcohol or any other substance abuse Gout Eating disorders Allergy Unregulated thyroid disease Asthma Eczema Hay fever Gluten/wheat intolerance Psychiatric disorder resulting in a perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioral disorders)

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, Scotland, AB21 9SB, United Kingdom

Location

Related Publications (1)

• Neacsu M, Vaughan NJ, Multari S, Haljas E, Scobbie L, Duncan GJ, Cantlay L, Fyfe C, Anderson S, Horgan G, Johnstone AM, Russell WR. Hemp and buckwheat are valuable sources of dietary amino acids, beneficially modulating gastrointestinal hormones and promoting satiety in healthy volunteers. Eur J Nutr. 2022 Mar;61(2):1057-1072. doi: 10.1007/s00394-021-02711-z. Epub 2021 Oct 30.

  PMID: 34716790 DERIVED

Study Officials

• Alexandra M Johnstone, PhD

  Rowett Institute of Nutrition and Health, University of Aberdeen, Scotland, UK

  PRINCIPAL INVESTIGATOR

• Madalina Neacsu, PhD

  Rowett Institute of Nutrition and Health, University of Aberdeen, Scotland, UK

  PRINCIPAL INVESTIGATOR

• Wendy R Russell, PhD

  Rowett Institute of Nutrition and Health, University of Aberdeen, Scotland, UK

  PRINCIPAL INVESTIGATOR

• Sandra Carlisle, PhD

  Rowett Institute of Nutrition and Health, University of Aberdeen, Scotland, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

GB (1)