PROCAL

CompletedPhase NA

The Dose Response of Calcium Co-ingested With Protein on GLP-1 Concentrations

The Dose Response of Milk Minerals High in Calcium With Protein on Plasma Glucagon-Like Peptide-1 Concentrations

Lead sponsor

University of Bath

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

•BMI 25-34.9

Primary endpoint

•Total plasma glucagon-like peptide-1 concentrations

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03819972

Org study IDPROCAL-JW

Timeline

Milestones

Study first posted2019-01-29actual

Study start2019-02-02actual

Primary completion2020-03-31actual

Study completion2021-03-31actual

Last update posted2021-04-28actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body mass index 25.0-34.9 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)

Exclusion criteria

•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 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%)

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Plasma insulin concentrations

Time frame:4 hours

concentration, descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Total plasma glucagon-like peptide-1 concentrations

Time frame:4 hours

concentration, descriptive