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Replace Glycemic Load and Satiety Study

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01516333
Enrollment
26
Registered
2012-01-24
Start date
2007-02-28
Completion date
2007-06-30
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Blood, Glycemic Index

Keywords

glycemic Index

Brief summary

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.

Detailed description

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.

Interventions

OTHERHigh GL 107

Three meals a day

OTHERMedium GL 76

Three meals a day

OTHERMedium GL 68

Three meals a day

OTHERLow GL 48

Three meals a day

Sponsors

General Mills
CollaboratorINDUSTRY
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Glucose over time1 monthBlood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.

Secondary

MeasureTime frameDescription
Visual Analog scores (VAS)1 monthHunger, satiety, and vigor will be measured by the visual analog scales.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026