Calcium and Gut Hormones

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

The Effect of Calcium 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 stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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

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

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.
  • 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Water with artificial sweetener
Dietary supplement: Control
Water with 80 mg sucralose
Experimental: Milk mineral supplement
Milk Minerals containing 1000 mg calcium with artificial sweetener and water
Dietary supplement: Milk mineral supplement
Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose

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

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_164C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Share anonymised data in publication form

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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