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Trial record 33 of 7501 for:    Area Under Curve

Calcium-protein Co-ingestion and Gut Hormones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370497
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Dietary Supplement: Milk Mineral Supplement Dietary Supplement: Whey Protein Hydrolysate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised, double-blind crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Acute Effects of Calcium-protein Co-ingestion on Gut Hormone Secretion
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Whey protein hydrolysate
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.
Dietary Supplement: Whey Protein Hydrolysate
50 g whey protein hydrolysate

Experimental: Whey protein hydrolysate plus milk mineral supplement
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.
Dietary Supplement: Milk Mineral Supplement
Milk Minerals containing 1000 mg calcium

Dietary Supplement: Whey Protein Hydrolysate
50 g whey protein hydrolysate




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370497


Locations
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United Kingdom
Department for Health, University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javier Gonzalez, Associate Professor, University of Bath
ClinicalTrials.gov Identifier: NCT03370497     History of Changes
Other Study ID Numbers: REACH EP 16/17_164B
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised data will be shared with publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Calcium, Dietary
Hormones
Calcium
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents