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Completed

NCT Number: NCT00798408

The Body's Response to Food Intake in Older Adults

We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. The results of these studies will provide further evidence to support that nutrition may provide safe and effective non-pharmacological therapies to counter the compromised regulation of energy balance experienced by many elderly people.

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Key information

Conditions

Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range: 60 years and older
  • Body mass index between 20-29 kg/m2
  • Weight stable (< 2 kg weight change within last 6 months)
  • Non-smoking
  • Constant habitual activity patterns within last 3 months
  • Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose <110 mg/dl)
  • Not taking medications known to influence appetite or metabolism
  • Non-diabetic
  • Resistive exercise training (≤2 times a week) based on reported physical activity levels (questionnaire)
  • Active fitness level (≤3, 30-minute aerobic exercise sessions/week)
  • Confirmation of acceptability of eating the study test foods (solids and fluids)

Exclusion criteria

  • Age: <60 years
  • Body mass index: outside of the 20-29 kg/m2 range
  • Gained or lost > 4.5 kg within the last 6 months
  • Smoker (currently or within the last year)
  • Intermittently been involved in a diet and/or exercise program within the last 3 months
  • Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
  • Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
  • Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
  • Clinically diagnosed as diabetic
  • Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
  • Perform ≥ 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels (questionnaire)
  • Study foods are found to be unacceptable for consumption by the subject

Treatment and study plan

Fluid Supplement

Dietary Supplement

The fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients

Solid Supplement

Dietary Supplement

The solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients

Primary outcomes

  1. Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women

    Time frame: 3 weeks

Secondary outcomes

  1. Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and post-prandial energy expenditure to the differential appetitive responses to fluid versus solid foods in untrained older men and women

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 26, 2008
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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