Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Metabolic Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: There are 4 conditions where participants will ingest different forms of protein in the presence or absence of calcium.Masking: Double (Participant, Investigator)Masking Description: Participant will not be told which drink they will ingest until the end of the study. Individuals not collaborating on the study will randomise the drink order and make up the drinks so the investigator is blinded to which drink the participant will ingest.Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Recent work at the University of Bath has shown that when ingested with 50 g whey protein hydrolysate, Capolac® (milk minerals high in calcium) potently stimulates availability of the important hormone glucagon-like peptide-1 (GLP-1). However, it is currently unclear how the form of protein ingested...

Recent work at the University of Bath has shown that when ingested with 50 g whey protein hydrolysate, Capolac® (milk minerals high in calcium) potently stimulates availability of the important hormone glucagon-like peptide-1 (GLP-1). However, it is currently unclear how the form of protein ingested with the presence or absence of calcium may affect gut hormone secretion and gastric emptying. Therefore we aim to perform a study on the effect of co-ingesting two different forms of protein in the presence or absence of calcium on gut hormone availability and gastric emptying. This project will help provide key evidence to aid future work and recommendations for nutrition-based interventions for the prevention and management of obesity and T2D. Fifteen metabolically healthy men and women, age 18-65 years, BMI between 18.5 and 25 kg/m2 will be recruited to participate in a randomised crossover study. Each participant will undergo 4 trials. Each trial will last ~3 hours and will be separated by a minimum of 48h: CONTROL (CON) - 30 g Control protein only CONTROL + CALCIUM (CON-C) - 30 g Control protein + 9547 mg Capolac® (2500 mg of calcium ingested) PROTEIN (PRO) - 30 g Aggregate protein only PROTEIN + CALCIUM (PRO-C) - 30 g Aggregate protein + 9547 mg Capolac® (2500 mg of calcium ingested) Each of these drinks will also contain 500 mL of water, low calorie sweetener (80 mg sucralose) and will be labelled with 150 mg 13C1 sodium acetate, and 100 mg 13C1 sodium octanoate for the measurement of gastric emptying. Participants will be asked to arrive to the laboratory between 09:00 and 10:00 am after not eating for between 10-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Upon arrival at the laboratory a trained phlebotomist staff member will insert a cannula (a small plastic tube) into a pre-heated dorsal hand vein on the back of the hand, or if unsuccessful, the antecubital vein. Participants will then be given one of the four test drinks, which once ingested will initiate the trial. Just after the ingestion of the test drink we will ask participants to fill out a palatability scale. Blood samples will be taken at baseline, and at 15, 30, 45, 60, 90, and 120 minutes after ingestion of the test drink. Breath samples will be collected in exetainers at baseline, and every 5 minutes until the 120-minute time point to determine gastric emptying. An appetite questionnaire will also be completed at baseline and every 60 minutes after ingestion of the test drink to assess appetite sensations. After the 120-minute time point participants will be asked to consume a lunch meal until they are comfortably full. Once satisfied with the lunch meal they will fill out the final appetite questionnaire. The trial day will then be complete. Following study completion participants will be asked to complete a restrained eating questionnaire. A subset of 5 participants will be fitted with a nasogastric tube by a qualified BAPEN nurse. 5ml aspirate from the stomach will be samples at baseline, 30, 60, and 120 minutes which will be distributed equally for analyte profiling and in vitro culture work. 3 ml gastric aspirate will be used to stimulate a GLUTag cell line. Experiments will be performed by incubating cells with the neutralised gastric aspirate in 250 µl Krebs Ringer Buffer (KRB) for 2 h at 37?C, 5 % CO2. A second culture, identical to that previously described will be conducted, only with the addition of specific cell receptor antagonists.

Tracking Information

NCT #
NCT04659902
Collaborators
Arla Foods
Investigators
Not Provided