NCT00948038

Brief Summary

The objective of this study is to determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2007

Typical duration 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

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

1.9 years

First QC Date

July 28, 2009

Last Update Submit

July 28, 2009

Conditions

ObesityOverweight

Keywords

InflammationOxidative stress

Outcome Measures

Primary Outcomes (8)

  • Plasma malondialdehyde

    28 days

  • Plasma 8-isoprostane F2-alpha

    28 days

  • Plasma tumor necrosis factor alpha

    28 days

  • plasma interleukin 6

    28 days

  • Plasma C-reactive protein

    28 days

  • Plasma MCP-1

    28-days

  • Plasma interleukin 15

    28 days

  • Plasma adiponectin

    28 days

Secondary Outcomes (4)

  • Plasma lipids

    28 days

  • Plasma insulin

    28 days

  • vitamin D

    28 days

  • Body composition

    28 days

Study Arms (2)

Soy

ACTIVE COMPARATOR

Soy-based supplement to normal diet

Dietary Supplement: Soy

Milk

EXPERIMENTAL

Milk-based supplement to normal diet

Dietary Supplement: Milk

Interventions

MilkDIETARY_SUPPLEMENT

Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day.

Milk
SoyDIETARY_SUPPLEMENT

Soy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days,

Soy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) 25-29.9 (n=10); 30-34.9 kg/m2 (n=10)
  • Age 18-50 years
  • Weight stable: no more than 3 kg weight loss during past three months

You may not qualify if:

  • BMI \< 25 or \>35
  • Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
  • Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
  • history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
  • history of eating disorder
  • presence of active gastrointestinal disorders such as malabsorption syndromes
  • pregnancy or lactation
  • use of obesity pharmacotherapeutic agents within the last 6 months
  • use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months
  • Recent (current or past 12 weeks) use of any psychotropic medication
  • Recent (past four weeks) initiation of an exercise program
  • Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
  • Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
  • Recent (current or past 12 weeks) history of smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

ObesityOverweightInflammation

Interventions

Milk

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

US(1)