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

NCT03819972 | Completed

• 1 other identifier: PROCAL-JW
• Study Type: interventional
• Target: 18
• 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. One of the most important hormones is called GLP-1. The food we eat influences the release of this hormone and evidence suggests that protein and calcium are key nutrients that stimulate the secretion of GLP-1. We want to know if there is a dose related response by increasing the amount of calcium ingested with a constant amount of protein on the release of this hormone. We hypothesise that with increasing calcium dose we will see an increase in GLP-1 concentrations in a curvilinear pattern. This may have benefits for prescribing an optimal dose of calcium for weight maintenance and health.

Conditions

GLP-1 Concentration

Outcome Measures

Primary Outcomes (1)

• Total plasma glucagon-like peptide-1 concentrations

  Blood sampling

  4 hours

Secondary Outcomes (7)

• Active plasma glucagon-like peptide-1 concentrations

  4 hours

• Plasma insulin concentrations

  4 hours

• Plasma NEFA concentrations

  4 hours

• Plasma albumin concentrations

  4 hours

• Serum calcium concentrations

  4 hours

Study Arms (4)

Control

PLACEBO COMPARATOR

Participants will ingest a drink containing 25 g whey protein hydrolysate (227 mg of total calcium ingested)

Dietary Supplement: Dose response of Capolac®

Dose 1

ACTIVE COMPARATOR

Participants will ingest a drink containing 25 g whey protein hydrolysate and 3179 mg Capolac (984 mg of total calcium ingested)

Dietary Supplement: Dose response of Capolac®

Dose 2

ACTIVE COMPARATOR

Participants will ingest a drink containing 25 g whey protein hydrolysate and 6363 mg Capolac (1742 mg of total calcium ingested)

Dietary Supplement: Dose response of Capolac®

Dose 3

ACTIVE COMPARATOR

Participants will ingest a drink containing 25 g whey protein hydrolysate and 9547 mg Capolac (2500 mg of total calcium ingested)

Dietary Supplement: Dose response of Capolac®

Interventions

Dose response of Capolac® DIETARY_SUPPLEMENT

Capolac® (milk minerals high in calcium) dose is manipulated

Control; Dose 1; Dose 2; Dose 3

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 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)

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 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, Brunsgaard LH, Mikkelsen UR, Koumanov F, Betts JA, Gonzalez JT. Plasma glucagon-like peptide-1 responses to ingestion of protein with increasing doses of milk minerals rich in calcium. Br J Nutr. 2021 Aug 9:1-9. doi: 10.1017/S000711452100297X. Online ahead of print.

  PMID: 34369333 DERIVED

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 particpant will ingest.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: There are 4 conditions where participants will ingest differing amounts of calcium in a randomised order

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 29, 2019
• Study Start: February 2, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)