Calcium and Gut Hormones

NCT ID: NCT03370484

Last Updated: 2018-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

Water with artificial sweetener

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Water with 80 mg sucralose

Milk mineral supplement

Milk Minerals containing 1000 mg calcium with artificial sweetener and water

Group Type EXPERIMENTAL

Milk mineral supplement

Intervention Type DIETARY_SUPPLEMENT

Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose

Interventions

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Control

Water with 80 mg sucralose

Intervention Type DIETARY_SUPPLEMENT

Milk mineral supplement

Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bath

OTHER

Sponsor Role lead

Responsible Party

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Javier Gonzalez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department for Health, University of Bath

Bath, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31531707 (View on PubMed)

Other Identifiers

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REACH EP 16/17_164C

Identifier Type: -

Identifier Source: org_study_id

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