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CompletedNCT03370484Updated Aug 28, 2018

Calcium and Gut Hormones

An interventional study of Control and Milk mineral supplement in Obesity and Diabetes, sponsored by University of Bath. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by University of Bath · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Diabetes
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • Placebo comparator
    Control

    Water with artificial sweetener

    Dietary Supplement: Control

  • Experimental
    Milk mineral supplement

    Milk Minerals containing 1000 mg calcium with artificial sweetener and water

    Dietary Supplement: Milk mineral supplement

Interventions

  • Dietary supplementControl

    Water with 80 mg sucralose

  • Dietary supplementMilk mineral supplement

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 120 min

Secondary outcomes

  1. Postprandial plasma GIP area under the curve (mmol/L x 120 min)

    Postprandial plasma GIP area under the curve (mmol/L x 120 min)

    Time frame: 120 min

  2. Postprandial plasma PYY area under the curve (mmol/L x 120 min)

    Postprandial plasma PYY area under the curve (mmol/L x 120 min)

    Time frame: 120 min

  3. Subjective ratings of appetite (au)

    Subjective ratings of appetite (au)

    Time frame: 120 min

06

Study locations

1 site
  • Department for Health, University of Bath
    Bath, BA2 7AY, United Kingdom
07

References and documents

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. PubMed 31531707 ↗

Individual participant data

Plan to share: No — Share anonymised data in publication form

08

Registry details

Key details

Study ID
NCT03370484
Lead sponsor
University of Bath
Responsible party
Javier Gonzalez (Associate Professor, University of Bath) — Principal investigator
First posted
Dec 12, 2017
Start date
Oct 1, 2017
Primary completion
Jan 31, 2018
Completion
Feb 28, 2018
Last update
Aug 28, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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