Clinical trial NCT06406270: Alternative Protein Short Chronic Study
Official title: Alternative Protein Short Chronic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day
timeFrame: 7-days
measure: Satiety levels following the consumption of buckwheat and fava bean-based diets.
timeFrame: every hour for 16 hours during the day for 7 days
measure: Hourly hunger scores analysed using VAS
timeFrame: every hour for 16 hours during the day for 7 days
measure: Concentrations of plasma, urine, and faecal samples of microbial metabolites of carbohydrates, protein, and bioactive phytochemicals.
timeFrame: Baseline and day 7
measure: Gut microbiota composition: Bacterial DNA extraction and sequencing using 16sRNA to determine the bacterial composition following the two different vegetarian-based diets.
timeFrame: 7-days
Secondary outcomes:
measure: Values concentration (μM) of fasted homocysteine
timeFrame: 7-days
measure: Values concentration (mmol/l) of fasted lipids, urea, and glucose
timeFrame: 7-days
measure: Values concentration (pmol/l) of fasted insulin
timeFrame: 7-days
Other outcomes:
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