NCT01961674

Brief Summary

The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging. The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

October 10, 2013

Last Update Submit

February 1, 2016

Conditions

ObesityDiabetesImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Temperature at supraclavicular region

    The temperature at the supraclavicular region following consumption of capsinoids will be determined using infrared thermal imaging.

    2.5 hours post-consumption

Secondary Outcomes (1)

  • Glycaemic response

    2.5 hours post-consumption

Study Arms (2)

Capsinoid arm

EXPERIMENTAL

On capsinoids

Dietary Supplement: Capsinoid/placebo and rice

Placebo arm

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Capsinoid/placebo and rice

Interventions

Capsinoid/placebo and riceDIETARY_SUPPLEMENT

The subject will ingest six capsinoid/placebo capsules and a standardized amount of white rice (equivalent to 50g carbohydrates). Each capsule consists 1.5mg of capsinoids, making a total dose of 9mg capsinoids.

Capsinoid armPlacebo arm

Eligibility Criteria

Age21 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese ethnicity
  • Male
  • Healthy
  • Age 21 - 30 years
  • BMI 18.0 - 22.9 kg/m2
  • Not on any prescribed medication
  • Infrequent spicy food or chilli user (less than 3 times per week)

You may not qualify if:

  • Smoker
  • Fasting blood glucose \> 5.5 mmol/L
  • Resting blood pressure \> 140/90 mmHg
  • Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
  • Allergic or intolerant to foods presented in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Design

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

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 11, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

SG(1)