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Psychological Phenomena and ProcessesFSNCT01050101

The Effects of Fiber on Appetite and Digestion Hormones

A study testing No fiber, Low GI high fiber viscous meal and Low GI high fiber non-viscous in people with Psychological Phenomena and Processes and Nutrition Physiological Phenomena, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
No fiber, Low GI high fiber viscous meal and Low GI high fiber non-viscous
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Aug 2008to 19 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female
  • 18 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Clinical Nutrition Research Center

    Chicago, Illinois, 60616

Other trials in United States

About this study

Official title: The Effect of Meal Viscosity on Postprandial Metabolic, Gut Hormone and Satiety Responses to Low and High Glycemic Index Preload Meals in Overweight Pre- and Post-menopausal Women.

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.

Read the detailed description

This study is designed to gain a better understanding of meal viscosity and the utility of dietary sources of viscous polysaccharide fibers to modulate postprandial metabolic and satiety mechanisms in pre- and post- menopausal overweight women in order to optimize acute metabolic responses to meals as well as most favorably affect appetite, food intake and overall body weight control.

Objectives of this study include:

  1. To investigate the effects of viscous polysaccharide type fibers in a meal on postprandial intestinal-phase mechanisms of satiety [eg., cholecystokinin (CCK)] and meal-associated metabolic (eg., glucose, insulin, triglyceride) response patterns to low glycemic index (GI), fiber-controlled preload meals compared to a low fiber, high GI meal in overweight pre- and post- menopausal women.
  2. 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 in overweight pre- and post- menopausal women.
  3. To examine the influence of menopausal status of overweight women on the physiological, subjective and behavioral responses to study preloads.

The study is a randomized, 3-arm, 6-sequence, within-subjects, crossover, treatment-controlled study utilizing a repeated measures, multiple sampling paradigm to evaluate the metabolic and satiety response pattern to low glycemic index (GI) fiber-controlled preload treatments differing in viscous fiber content compared to a high GI preload meal.

The study will test 3 isocaloric treatment preloads in relatively healthy overweight, mildly obese, pre- and post- menopausal women. Preload meals will be prepared as breakfast meals using muffins and yogurt beverage / shake as the base for which glycemic index (GI) of the meal, including fiber / viscous fiber content, will be manipulated. All preloads have been matched as close as possible on sensory qualities as well as macronutrient composition, fiber and energy content and volume.

The 3 treatments will include as fiber source either viscous polysaccharide fiber source, eg., psyllium husk, and insoluble non-viscous producing fiber source, eg., cellulose, respectively. These fibers are commercially available.

Preload meals will be prepared to contain about 1 kcal/g offered as a 600 kcal meal portion. The macronutrient distribution for fat, carbohydrate and protein will be 30%, 55% and 15% of energy, respectively. Fiber will be included at 2 levels: 2 g/100 kcal for the 2 fiber containing preload meals and no fiber for the high GI low fiber control. These levels of fiber are consistent with our previously studied breakfast meals and for the higher fiber meals, just above the recommended intake for adult Americans. Preload meals will be matched as closely as possible on micronutrients and sensory (palatability, sweetness, texture) quality.

Preload meals be provided under fasting conditions and consumed within 20 minutes. Subsequent food intake will be measured in lab at a test meal and then by food records at home thereafter.

Subjects will receive each preload meal in random order ~ 1 month apart in order to standardize cyclic phase within the pre-menopausal group. Each preload test session will include collection of food records and menstrual logs, in-lab preload and test meal consumption, multiple blood sampling and visual analog scale completion.

Blood sample collection and visual analog scale (VAS) completion will occur before (fasting, time 0) preload meal consumption and then at 20, 40, 60, 90, 120, 150, and 180 min thereafter. A test meal lunch will be offered 2.5 h post-preload meal consumption. Test meal will be provided ad libitum. Final two blood draws and satiety evaluation will occur after lunch (210 and 240 minutes).

Blood will be measured for glucose, insulin, triglycerides and CCK at the specific time periods listed above. Occuring at the same time period, the subject will complete the VAS, a validated method for assessing subjective measures of appetite. Subjects will also rate the preload meals using the VAS on a number of sensory qualities to assess palatability.

Being tested
No fiber, Low GI high fiber viscous meal, Low GI high fiber non-viscous
Keywords
Satiety, Fiber, Nutrition, Pre- and post-menopausal women, overweight
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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 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.

Study groups in NCT01050101
Study groupRoleWhat they receive
High GI low fiber mealPlacebo comparatorNo fiber control meal
Receives: Dietary Supplement: No fiber
Low GI high fiber viscous mealActive comparator80:20 ratio of viscous polysaccharide fiber to insoluble non-viscous producing fiber
Receives: Dietary Supplement: Low GI high fiber viscous meal
Low GI high fiber non-viscous mealActive comparator20:80 ratio of viscous polysaccharide fiber source to insoluble non-viscous producing fiber
Receives: Dietary Supplement: Low GI high fiber non-viscous

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Effect of Different Treatments on Cholecystokinin (CCK) Concentration

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

  2. 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

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

Secondary outcomes (1)
  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.

    Satiety measured by Three-Factor Eating Questionnaire

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2010 (estimated)
  2. Study start1 Aug 2008
  3. Primary completion1 Dec 2018
  4. Study completion19 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01050101
Sponsor's protocol ID
FS 2009-052
Acronym
FS
Status last verified
Jan 2021
First submitted
13 Jan 2010
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14649371
  • 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.

    PubMed 15051857
  • 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.

    PubMed 15930445
  • 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.

    PubMed 14652359
  • 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.

    PubMed 12198015
  • 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.

    PubMed 15531667

Questions about this trial

What is this clinical trial studying?

A study testing No fiber, Low GI high fiber viscous meal and Low GI high fiber non-viscous in people with Psychological Phenomena and Processes and Nutrition Physiological Phenomena, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the effects of viscous polysaccharide fibers on postprandial satiety. (time frame: 0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01050101, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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