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Trial record 34 of 8137 for:    complementary OR alternative OR integrative AND yoga

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

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ClinicalTrials.gov Identifier: NCT01898351
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Health Impacts of Sustainable Ingredient Selection in the Food and Drink Industry - ALTERNATIVE PROTEIN STUDY
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat

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

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.





Primary Outcome Measures :
  1. Postprandial effects (including satiety )of a pea, fava bean, lupin, hemp, buckwheat in comparison with meat in healthy people. [ Time Frame: up to 3 months ]

    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.



Secondary Outcome Measures :
  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. [ Time Frame: up to 3 months ]

    The 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

    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.



Other Outcome Measures:
  1. Volunteer views towards diets rich in plant proteins will be assessed. [ Time Frame: The assesment will take place during one of the interventtion visits of the study and will be around one hour long. ]
    With regard to the social science component of the project, in-depth semi-structured interviews will be used for assessing the volunteers view towards diets rich in alternative plant proteins. For each volunteer will be conducted an digitally recorded interview(one hour), during one of the scheduled visits at the Human Nutrition Unit, once initial screening has taken place and participants have been selected.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy males and females, non-vegetarians, non-smokers, age 18-65 with BMI 18-35 kg m-2, taking no exclusion criteria medication.

Exclusion Criteria:

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)

Medication exclusion criteria (Confirmed with GP) Orlistat (Xenical) Oral antidiabetics, insulin Digoxin, anti-arrhythmics Anti-inflammatories/anti-pyretics Tricyclic antidepressants, neuroleptics Antihistamines


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): NCT01898351


Locations
United Kingdom
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, Scotland, United Kingdom, AB21 9SB
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: 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

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01898351     History of Changes
Other Study ID Numbers: Alternative Protein Study 791
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by University of Aberdeen:
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