The Effects of Fiber on Appetite and Digestion Hormones



Status:Active, not recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:August 1, 2008
End Date:November 14, 2019

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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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
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