Calcium, Protein and Gut Hormones

NCT03232034 | Completed

• 1 other identifier: REACH EP 16/17_164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Diabetes

Keywords

Calcium citrate, dairy product, whey protein, appetite, metabolism

Outcome Measures

Primary Outcomes (1)

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

  Plasma glucagon-like peptide-1 (GLP-1) concentrations

  120 min

Secondary Outcomes (6)

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

  120 min

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

  120 min

• Subjective ratings of appetite (au)

  120 min

• Energy metabolism (carbohydrate and fat oxidation)

  120 min

• Postprandial plasma glucose

  120 min

Study Arms (3)

Calcium Citrate

PLACEBO COMPARATOR

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.

Dietary Supplement: Calcium Citrate

Milk Mineral Supplement

ACTIVE COMPARATOR

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.

Dietary Supplement: Milk Mineral Supplement

Milk mineral supplement plus Whey Protein Hydrolysate

EXPERIMENTAL

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; Dietary Supplement: Whey Protein Hydrolysate

Interventions

Calcium Citrate DIETARY_SUPPLEMENT

1000 mg calcium as calcium citrate

Calcium Citrate

Milk Mineral Supplement DIETARY_SUPPLEMENT

Milk Minerals containing 1000 mg calcium

Milk Mineral Supplement; Milk mineral supplement plus Whey Protein Hydrolysate

Whey Protein Hydrolysate DIETARY_SUPPLEMENT

50 g whey protein hydrolysate

Milk mineral supplement plus Whey Protein Hydrolysate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31531707 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Calcium Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Researchers will be blinded to the interventions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (Assistant Professor) in Human Physiology

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: May 1, 2017
• Primary Completion: December 5, 2017
• Study Completion: January 31, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

GB (1)