Calcium, Protein and Gut Hormones

NCT ID: NCT03232034

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-01-31

Brief Summary

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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 CapolacĀ® plus protein on circulating gut hormone responses.

Detailed Description

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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.

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

DOUBLE

Participants Investigators
Participants and Researchers will be blinded to the interventions.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Calcium Citrate

Intervention Type DIETARY_SUPPLEMENT

1000 mg calcium as calcium citrate

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.

Group Type ACTIVE_COMPARATOR

Milk Mineral Supplement

Intervention Type DIETARY_SUPPLEMENT

Milk Minerals containing 1000 mg calcium

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.

Group Type EXPERIMENTAL

Milk Mineral Supplement

Intervention Type DIETARY_SUPPLEMENT

Milk Minerals containing 1000 mg calcium

Whey Protein Hydrolysate

Intervention Type DIETARY_SUPPLEMENT

50 g whey protein hydrolysate

Interventions

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Calcium Citrate

1000 mg calcium as calcium citrate

Intervention Type DIETARY_SUPPLEMENT

Milk Mineral Supplement

Milk Minerals containing 1000 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Whey Protein Hydrolysate

50 g whey protein hydrolysate

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.
* 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
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

Lecturer (Assistant Professor) in Human Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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_164

Identifier Type: -

Identifier Source: org_study_id

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