NCT01050101

Brief Summary

In this research study, investigators are interested in how certain dietary fibers in the diet affect certain hormones released from your intestine after eating and how these influence your appetite. The study hypothesis is that certain fibers will slow digestion and absorption of nutrients thereby optimizing fullness,reducing food intake and limiting insulin response in pre- and post-menopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

10.3 years

First QC Date

January 13, 2010

Last Update Submit

January 25, 2021

Conditions

Psychological Phenomena and ProcessesNutrition Physiological Phenomena

Keywords

SatietyFiberNutritionPre- and post-menopausal womenoverweight

Outcome Measures

Primary Outcomes (2)

  • To investigate the effects of viscous polysaccharide fibers on postprandial satiety.

    Effect of Different Treatments on Cholecystokinin (CCK) Concentration

    0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes

  • To investigate the effects of viscous polysaccharide fibers on postprandial meal-associated metabolic response patterns.

    Plasma glucose, insulin, and triglyceride concentrations measured by Randox Clinical analyzer

    0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes

Secondary Outcomes (1)

  • To characterize the subjective and behavioral satiety responses to study-specific preload meals varying in viscous fiber content as well as determine the relationship of these satiety responses to the preload-associated physiological responses.

    0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes

Study Arms (3)

High GI low fiber meal

PLACEBO COMPARATOR

No fiber control meal

Dietary Supplement: No fiber

Low GI high fiber viscous meal

ACTIVE COMPARATOR

80:20 ratio of viscous polysaccharide fiber to insoluble non-viscous producing fiber

Dietary Supplement: Low GI high fiber viscous meal

Low GI high fiber non-viscous meal

ACTIVE COMPARATOR

20:80 ratio of viscous polysaccharide fiber source to insoluble non-viscous producing fiber

Dietary Supplement: Low GI high fiber non-viscous

Interventions

No fiberDIETARY_SUPPLEMENT

The High GI low fiber meal consists of 0 grams fiber with total kcal of 573 with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.

High GI low fiber meal
Low GI high fiber viscous mealDIETARY_SUPPLEMENT

Test meal consists of 12 grams of fiber (9 grams soluble and 3 grams insoluble). The ratio is 80:20 ratio of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose). Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.

Low GI high fiber viscous meal
Low GI high fiber non-viscousDIETARY_SUPPLEMENT

Test meal consists of 11 grams of fiber (3 grams soluble and 8 grams insoluble). The ratio is 20:80 of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose). Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.

Low GI high fiber non-viscous meal

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • years or older
  • Unrestrained \[score ≤ 10\] on the Eating Inventory (EI) questionnaire
  • Pre-menopausal with spontaneous cycle
  • Post-menopausal ≥ 12 month without menstruation
  • Body mass index (BMI) of either 25 to 33 kg/m2, inclusive

You may not qualify if:

  • Pregnant and lactating
  • Smoking
  • Allergies or intolerances to foods consumed in the study
  • Fasting glucose \> 110 mg/dL
  • Active modification to diet or exercise patterns to gain or lose weight in previous 60 days
  • Unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
  • Excessive exercisers or trained athletes
  • Taking any medications that would affect appetite or have a current or past (previous 1 year) medical condition that may interfere with any of the outcomes of this study.
  • Hormonal therapy (ie., estrogen, progesterone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (6)

  • Almiron-Roig E, Chen Y, Drewnowski A. Liquid calories and the failure of satiety: how good is the evidence? Obes Rev. 2003 Nov;4(4):201-12. doi: 10.1046/j.1467-789x.2003.00112.x.

    PMID: 14649371BACKGROUND

  • Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.

    PMID: 15051857BACKGROUND

  • Burton-Freeman B. Sex and cognitive dietary restraint influence cholecystokinin release and satiety in response to preloads varying in fatty acid composition and content. J Nutr. 2005 Jun;135(6):1407-14. doi: 10.1093/jn/135.6.1407.

    PMID: 15930445BACKGROUND

  • Schneeman BO, Burton-Freeman B, Davis P. Incorporating dairy foods into low and high fat diets increases the postprandial cholecystokinin response in men and women. J Nutr. 2003 Dec;133(12):4124-8. doi: 10.1093/jn/133.12.4124.

    PMID: 14652359BACKGROUND

  • Burton-Freeman B, Davis PA, Schneeman BO. Plasma cholecystokinin is associated with subjective measures of satiety in women. Am J Clin Nutr. 2002 Sep;76(3):659-67. doi: 10.1093/ajcn/76.3.659.

    PMID: 12198015BACKGROUND

  • Burton-Freeman B, Davis PA, Schneeman BO. Interaction of fat availability and sex on postprandial satiety and cholecystokinin after mixed-food meals. Am J Clin Nutr. 2004 Nov;80(5):1207-14. doi: 10.1093/ajcn/80.5.1207.

    PMID: 15531667BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Britt Burton-Freeman, MS, PhD

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

August 1, 2008

Primary Completion

December 1, 2018

Study Completion

December 19, 2018

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)