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Completed

NCT Number: NCT06406270

Alternative Protein Short Chronic Study

The world's population needs adequate food supply to sustain food security. The availability of sufficient dietary protein is undeniably a source of concern for human health. This study aimed to assess the satiety and potential health benefits of two types of vegetarian diets when the meat was replaced with buckwheat and respectively fava bean for one-week in the diet of healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The World Health Organisation (WHO) recommends increasing the intake of fruits and vegetables, legumes, whole grains and nuts to prevent obesity. In Western countries, there is a greater understanding of the health benefits of pulse grains. Consumption of whole grain cereals and grain pulses has been shown to protect against a variety of inflammation-related chronic diseases. Grain cereals, pulses and pseudo cereals are also good dietary protein sources. This study aimed to assess the suitability of buckwheat and fava bean to replace meat for one week in terms of delivering adequate nutrient intake, satisfying hunger and delivering potential health benefits. The composition of human microbial metabolites and the bacterial composition after consumption of the intervention diets by healthy volunteers for one week were also assessed. This study offers data to support the potential of plants as alternative sources of dietary nutrients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and females,
  • Non-vegetarian,
  • non-smokers,
  • age 18-65
  • with BMI 18-35 kg/m.

Exclusion criteria

  • vegetarian,
  • smoker,
  • having known allergies,
  • using prescription drugs.
  • diabetes,
  • gastrointestinal disorders,
  • kidney disease,
  • hepatic disease,
  • favism,
  • alcohol or
  • substance abuse

Treatment and study plan

Fava

Other

Participants were instructed to consume only the meals that were provided to them during the study days. The breakfast, lunch and dinner meals of the diets were designed to contain 30% fat, 15% protein, and 55% carbohydrate, and seven different menus (1500, 1750, 2000, 2250, 2500, 2750 and 3000 Kcal) to deliver the closest energy requirements of the volunteers. For the intervention diets, all the meat was replaced with fava bean food products, serving the same amount of buckwheat and fava bean food products for all the volunteers independently of their energy requirements. During the intervention diets, all the drinks, such as coffee, juice and tea, were restricted and provided by the Human Nutrition Unit at the Rowett Institute; the volunteers were allowed to drink only water ad libitum. Alcoholic drinks were not allowed to be consumed during the intervention diet weeks.

Buckwheat

Other

Participants were instructed to consume only the meals that were provided to them during the study days. The breakfast, lunch and dinner meals of the diets were designed to contain 30% fat, 15% protein, and 55% carbohydrate, and seven different menus (1500, 1750, 2000, 2250, 2500, 2750 and 3000 Kcal) to deliver the closest energy requirements of the volunteers. For the intervention diets, all the meat was replaced with buckwheat food products, serving the same amount of buckwheat and fava bean food products for all the volunteers independently of their energy requirements. During the intervention diets, all the drinks, such as coffee, juice and tea, were restricted and provided by the Human Nutrition Unit at the Rowett Institute; the volunteers were allowed to drink only water ad libitum. Alcoholic drinks were not allowed to be consumed during the intervention diet weeks.

Primary outcomes

  1. The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day

    Time frame: 7-days

    The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day such as protein composition, amino acids composition, fibre composition, types of NSP, and daily requirements minerals, microelements, and other bioactive such as polyphenolic phytochemicals. The macronutrient composition, including the dry matter, ash, fat, total carbohydrate, resistant starch, crude protein, and total non-starch polysaccharides of the buckwheat and fava-bean diets are measured in grams per day. The amino acid composition was measured in grams per day and the main micronutrients expressed in mg ± SD per day are measured in fava bean and buckwheat diets using quantitative ICP-MS analysis.

  2. Satiety levels following the consumption of buckwheat and fava bean-based diets.

    Time frame: every hour for 16 hours during the day for 7 days

    Appetite scores were measured hourly during the waking hours (0700-2300) with the use of visual analogue scales (VASs) during both the habitual diet week and the intervention weeks (fava bean-based and buckwheat-based diets). Six questions were asked on motivation to eat, all in the line scale format related to hunger, thirst, preoccupation with thoughts of food, fullness, desire to eat, and prospective consumption. The scales ranged from "not at all hungry" to "extremely hungry," so higher scores indicated more intense subjective sensations. These questionnaires were completed by the subjects each day of the study.

  3. Hourly hunger scores analysed using VAS

    Time frame: every hour for 16 hours during the day for 7 days

    Hunger scores were measured hourly during the waking hours (0700-2300) with the use of visual analogue scales (VASs) during both the habitual diet week and the intervention weeks (fava bean-based and buckwheat-based diets). Six questions were asked on motivation to eat, all in the line scale format related to hunger, thirst, preoccupation with thoughts of food, fullness, desire to eat, and prospective consumption. The scales ranged from "not at all hungry" to "extremely hungry," so higher scores indicated more intense subjective sensations. These questionnaires were completed by the subjects each day of the study.

  4. Concentrations of plasma, urine, and faecal samples of microbial metabolites of carbohydrates, protein, and bioactive phytochemicals.

    Time frame: Baseline and day 7

    Concentrations of plasma, urine, and faecal samples of microbial metabolites of carbohydrates, protein and bioactive phytochemicals from the diets at day 0 and day 7 in fasted plasma, urine and faecal samples. Furthermore looked at fermentation products of carbohydrates in faecal samples. Average concentration was measured by targeted LC-MS/MS and expressed as pg/μl.

  5. Gut microbiota composition: Bacterial DNA extraction and sequencing using 16sRNA to determine the bacterial composition following the two different vegetarian-based diets.

    Time frame: 7-days

    The total number of 16S rRNA gene copies per ml and abundance of several bacterial genera or species of the communities in the anaerobic faecal incubation experiments was determined by quantitative PCR with 2 ng DNA in a total volume of 10 μl and expressed as 16S rRNA gene copies per ml of culture. The abundance of total faecal microbiota and specific genera were reported during habitual (baseline) diet and intervention diets consumption.

Secondary outcomes

  1. Values concentration (μM) of fasted homocysteine

    Time frame: 7-days

    Blood was collected directly into heparinised tubes at day 0 and 7 of each intervention diet. Homocysteine was expressed as μM.

  2. Values concentration (mmol/l) of fasted lipids, urea, and glucose

    Time frame: 7-days

    Blood was collected directly into heparinised tubes at day 0 and 7 of each intervention diet. Fasted lipids, urea and glucose were expressed as mmol/l.

  3. Values concentration (pmol/l) of fasted insulin

    Time frame: 7-days

    Blood was collected directly into heparinised tubes at day 0 and 7 of each intervention diet. Insulin was expressed as pmol/l.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Acronym: APSC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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