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Completed

NCT Number: NCT01516333

Replace Glycemic Load and Satiety Study

The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass index between 25-35 kg/m2
  • Fasting serum glucose
  • Fasting serum glucose < 125 mg/dl
  • Free of chronic disease
  • Willing to eat only the foods that are provided by the Center during the diet periods
  • Willing to abstain from the consumption of alcohol during the diet periods
  • Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
  • Monophasic birth control (same dose each day)
  • Hormone replacement therapy
  • Post-menopausal (over 1 year without bleeding)
  • Have had partial hysterectomy over the age of 55
  • complete hysterectomy at any age

Exclusion criteria

  • Documented presence of atherosclerotic disease
  • Diabetes mellitus
  • Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
  • Body Mass Index <25 or > 35
  • History of drug or alcohol abuse in the last year
  • For women, pregnancy, breast feeding or postpartum < 6 months
  • History of depression or mental illness requiring treatment or medication within that last 6 months
  • Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Lifestyle or schedule incompatible with the study protocol
  • Planned continued use of dietary supplements through the study trial
  • Smoking or tobacco use

Treatment and study plan

High GL 107

Other

Three meals a day

Medium GL 76

Other

Three meals a day

Medium GL 68

Other

Three meals a day

Low GL 48

Other

Three meals a day

Primary outcomes

  1. Blood Glucose over time

    Time frame: 1 month

    Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.

Secondary outcomes

  1. Visual Analog scores (VAS)

    Time frame: 1 month

    Hunger, satiety, and vigor will be measured by the visual analog scales.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • General Mills

Registry information

Official study title

Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 24, 2012
Registry last updated
Dec 18, 2015

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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