Protein, Calcium and Gut Hormone Secretion

NCT04659902 | Completed

• 1 other identifier: PROCAL2-JW
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Hormones that are produced by our stomach and intestines play a role in regulating our appetite and health, and are therefore of high interest for managing conditions such as obesity and Type 2 Diabetes (T2D). Two important hormones, called GLP-1 and PYY, are released from the same intestinal cell. The food we eat influences the release of these hormone and evidence suggests that protein and calcium are key nutrients that stimulate the secretion of GLP-1, while the influence of this combination on PYY release is less clear. Furthermore, gastric emptying affects the rate of absorption of nutrients and by manipulating the structural form of protein, in the absence or presence of calcium, we may be able to learn more about the processes mediating the gut hormone response. We hypothesise that gut hormone secretion will be enhanced following the ingestion of a partially digested protein in the presence of calcium versus a control protein without calcium. Additionally, the ingestion of the partially digested protein will result in faster gastric emptying compared to the control protein.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• incremental area under the curve (iAUC) for total plasma GLP-1

  Blood sampling

  2 hours

Secondary Outcomes (10)

• Gastric emptying

  2 hours

• in vitro gut hormone secretion

  2 hours

• iAUC for total PYY

  2 hours

• iAUC for plasma and gastric amino acid profile

  2 hours

• iAUC for plasma Dipeptidyl Peptidase-IV (DPP4)

  2 hours

Study Arms (4)

CON

PLACEBO COMPARATOR

Participants will ingest a drink containing a control protein only

Dietary Supplement: Protein form

CON-C

ACTIVE COMPARATOR

Participants will ingest a drink containing a control protein plus Capolac® (9547 mg to provide 2500mg of calcium)

Dietary Supplement: Protein form

PRO

ACTIVE COMPARATOR

Participants will ingest a drink containing an aggregate protein only

Dietary Supplement: Protein form

PRO-C

ACTIVE COMPARATOR

Participants will ingest a drink containing an aggregate protein plus Capolac® (9547 mg to provide 2500mg of calcium)

Dietary Supplement: Protein form

Interventions

Protein form DIETARY_SUPPLEMENT

Protein form and absence or presence of calcium manipulated

CON; CON-C; PRO; PRO-C

Eligibility Criteria

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

You may qualify if:

• Body mass index 18.5-25.0 kg∙m-2
• Age 18-65 years
• Able and willing to provide informed consent and safely comply with study procedures
• Females to maintain record of regular menstrual cycle phase or contraceptive use
• No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)

You may not qualify if:

• Allergies or adverse reactions to calcium or milk proteins.
• Contradictions to a high intake of calcium e.g. history of kidney stones
• Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
• Any diagnosed gastrointestinal or metabolic disease (e.g. type 1 or type 2 diabetes)
• Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
• Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
• Any reported recent (\<6 months) change in body mass (± 3%)

Sponsors & Collaborators

• University of Bath: lead
• Arla Foods: collaborator

Study Sites (1)

Department For Health, University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (1)

• Watkins JD, Smith HA, Hengist A, Nielsen SB, Mikkelsen UR, Saunders J, Koumanov F, Betts JA, Gonzalez JT. Effects of physical form of beta-lactoglobulin and calcium ingestion on GLP-1 secretion, gastric emptying and energy intake in humans: a randomised crossover trial. Br J Nutr. 2024 May 28;131(10):1730-1739. doi: 10.1017/S0007114524000321. Epub 2024 Jan 30.

  PMID: 38287700 DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Programme in Health

Model Details: There are 4 conditions where participants will ingest different forms of protein in the presence or absence of calcium.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)