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Completed

NCT Number: NCT03232034

Calcium, Protein and Gut Hormones

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bath

Bath, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcium citrate

Dietary Supplement

1000 mg calcium as calcium citrate

Milk Mineral Supplement

Dietary Supplement

Milk Minerals containing 1000 mg calcium

Whey Protein Hydrolysate

Dietary Supplement

50 g whey protein hydrolysate

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 120 min

    Plasma glucose-dependent insulinotropic peptide (GIP) concentrations

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

    Time frame: 120 min

    Plasma peptide tyrosine tyrosine (PYY) concentrations.

  3. Subjective ratings of appetite (au)

    Time frame: 120 min

    Visual analogue scales of appetite ratings

  4. Energy metabolism (carbohydrate and fat oxidation)

    Time frame: 120 min

    Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry

  5. Postprandial plasma glucose

    Time frame: 120 min

    Plasma glucose concentrations (mmol/L).

  6. Blood pressure

    Time frame: 120 min

    Systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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