NCT02894112

Brief Summary

Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed in the regular diet. Milk products are unique in that they produce high insulin response despite their low glycemic index. The general aim of the proposed study is to determine the effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride after meals and its associated physiological mechanisms. The investigators hypothesize that the consumption of one or two servings of non-fat milk added to a standard oral glucose tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the postulated improvement in postprandial metabolic response due to the consumption of fluid milk will be associated with increased postprandial insulin secretion as well as insulin-mediated endothelial vasodilation and whole-limb perfusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

August 30, 2016

Last Update Submit

September 2, 2016

Conditions

Oral Glucose Tolerance TestHigh Fat Tolerance Test

Keywords

endothelial dependent vasodilationblood flowblood glucosetriglyceridesnon-fat milkdairy

Outcome Measures

Primary Outcomes (2)

  • blood glucose

    2 hour postprandially

  • plasma triglyceride

    4 hour postprandially

Secondary Outcomes (2)

  • femoral artery blood flow

    2-4 hour postprandially

  • brachial artery flow-mediated dilation

    2-4 hour postprandially

Other Outcomes (4)

  • insulin

    2-4 hour postprandially

  • glucagon

    2-4 hour postprandially

  • GIP

    2-4 hour postprandially

  • +1 more other outcomes

Study Arms (2)

Oral glucose tolerance test

EXPERIMENTAL

100 g of glucose in a fruit punch flavored 8 oz drink

Dietary Supplement: non-fat milkDietary Supplement: carbohydrate control beverageDietary Supplement: caloric control beverage

High fat tolerance test

EXPERIMENTAL

single high fat load determined by body weight.

Dietary Supplement: non-fat milkDietary Supplement: carbohydrate control beverageDietary Supplement: caloric control beverage

Interventions

non-fat milkDIETARY_SUPPLEMENT

1 serving of non-fat fluid milk

High fat tolerance testOral glucose tolerance test
carbohydrate control beverageDIETARY_SUPPLEMENT

1 serving of carbohydrate control beverage (Carbohydrate powder + water)

High fat tolerance testOral glucose tolerance test
caloric control beverageDIETARY_SUPPLEMENT

1 serving of caloric control beverage (carbohydrate powder + protein powder + water)

High fat tolerance testOral glucose tolerance test

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently health, sedentary. All subjects will have a BMI of 25-35 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Aging Research Laboratory

Austin, Texas, 78702, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 9, 2016

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)