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Completed

NCT Number: NCT03370497

Calcium-protein Co-ingestion and Gut Hormones

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

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.
  • 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

Treatment and study plan

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

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

Secondary outcomes

  1. 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)

  2. 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)

  3. Subjective ratings of appetite (au)

    Time frame: 120 min

    Subjective ratings of appetite (au)

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

The Acute Effects of Calcium-protein Co-ingestion on Gut Hormone Secretion

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 12, 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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