NCT02137434

Brief Summary

The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

May 9, 2014

Last Update Submit

May 9, 2014

Conditions

Obesity

Keywords

Acute calciumDietary calciumSupplementary calciumPostprandial metabolism

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Blood pressure will be assessed by digital photoplethysmography.

    Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.

Secondary Outcomes (1)

  • Endothelial function

    Endothelial function will be assessed after meals' intake and 2 hours after it.

Other Outcomes (3)

  • Plasma triglycerides

    Plasma triglycerides will be assessed in the fasting period and each hour during three hours after meals' intake

  • Plasma glucose

    Plasma glucose will be assessed in the fasting period and each hour during three hours after meals' intake

  • Oxidative stress

    Oxidative stress will be assessed in the fasting period and each hour during three hours after meals' intake

Study Arms (3)

Low calcium fatty meal

PLACEBO COMPARATOR

Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 40 mg of calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates.

High dietary calcium fatty meal

EXPERIMENTAL

Fatty meal consisting of biscuit, butter and drink made of skimmed milk containing 540 mg of dietary calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates.

Other: Dietary calcium

High supplementary calcium fatty meal

EXPERIMENTAL

Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 540 mg of supplementary calcium from calcium carbonate, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates.

Dietary Supplement: Supplementary calcium

Interventions

Dietary calciumOTHER

Dietary calcium from skimmed milk

High dietary calcium fatty meal
Supplementary calciumDIETARY_SUPPLEMENT

Supplementary calcium from calcium carbonate

High supplementary calcium fatty meal

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2
  • habitual dietary calcium intake below 500 mg per day

You may not qualify if:

  • smoking
  • dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
  • diabetes
  • thyroid dysfunction
  • hypertension
  • angina pectoris
  • heart kidney or liver failure
  • intestinal malabsorption
  • acute or chronic inflammation
  • HIV infection
  • autoimmune diseases
  • cancer
  • chronic obstructive pulmonary disease
  • dyslipidemia with indication for drug treatment
  • history of myocardial infarction or stroke
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Calcium, Dietary

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic Chemicals

Study Officials

  • Antonio F Sanjuliani, PhD.

    Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaís S Ferreira, MSc.

CONTACT

55 21 2334-2063thaissferreira@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

BR(1)