Calcium, Protein and Gut Hormones

August 26, 2018 updated by: Javier Gonzalez, University of Bath

The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).

Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Weigh 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Calcium Citrate
Calcium citrate (1000 mg calcium) 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: Calcium Citrate
1000 mg calcium as calcium citrate
Active Comparator: Milk Mineral Supplement
Milk mineral supplement (equating to 1000 mg calcium) 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: Milk Mineral Supplement
Milk Minerals containing 1000 mg calcium
Experimental: Milk mineral supplement plus Whey Protein Hydrolysate
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).
Time Frame: 120 min
Plasma glucagon-like peptide-1 (GLP-1) concentrations
120 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial plasma GIP area under the curve (mmol/L x 120 min)
Time Frame: 120 min
Plasma glucose-dependent insulinotropic peptide (GIP) concentrations
120 min
Postprandial plasma PYY area under the curve (mmol/L x 120 min)
Time Frame: 120 min
Plasma peptide tyrosine tyrosine (PYY) concentrations.
120 min
Subjective ratings of appetite (au)
Time Frame: 120 min
Visual analogue scales of appetite ratings
120 min
Energy metabolism (carbohydrate and fat oxidation)
Time Frame: 120 min
Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry
120 min
Postprandial plasma glucose
Time Frame: 120 min
Plasma glucose concentrations (mmol/L).
120 min
Blood pressure
Time Frame: 120 min
Systolic and diastolic blood pressure
120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bath

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 27, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REACH EP 16/17_164

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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