Calcium-protein Co-ingestion and Gut Hormones

The Acute Effects of Calcium-protein Co-ingestion on Gut Hormone Secretion

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Dietary supplement: Whey Protein Hydrolysate; Dietary supplement: Milk Mineral Supplement

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Department for Health, University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy men and women age between 18-65 yrs.
• Able to consume provided supplement.
• Weight stable for the past 3 month (no change within 3%)

Exclusion Criteria:

• Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
• Not between the ages of 18-65 years
• A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
• Taking medications that may influence your metabolism
• Plans to change your lifestyle (diet and/or physical activity) during the study period
• Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
• Current smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whey protein hydrolysate; Whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.	Dietary supplement: Whey Protein Hydrolysate; 50 g whey protein hydrolysate
Experimental: Whey protein hydrolysate plus milk mineral supplement; Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion.	Dietary supplement: Whey Protein Hydrolysate; 50 g whey protein hydrolysate; Dietary supplement: Milk Mineral Supplement; Milk Minerals containing 1000 mg calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).	Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).	120 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial plasma GIP area under the curve (mmol/L x 120 min)	Postprandial plasma GIP area under the curve (mmol/L x 120 min)	120 min
Postprandial plasma PYY area under the curve (mmol/L x 120 min)	Postprandial plasma PYY area under the curve (mmol/L x 120 min)	120 min
Subjective ratings of appetite (au)	Subjective ratings of appetite (au)	120 min

Collaborators and Investigators

• Sponsor: University of Bath

Publications and helpful links

General Publications

• Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: REACH EP 16/17_164B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised data will be shared with publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No