Potato Research for Enhancing Metabolic Outcomes

Obesity Clinical Trial

— PREMO  

Official title:

Meat and Potato Diet for Enhancing Cardiometabolic Health in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203238
• Other study ID #: PBRC 2019-029
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: May 18, 2021

Study information

• Verified date: November 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The potato is a nutritious food that comprises approximately 30% of total vegetable intake in the United States (US). Consumption of pulses in the US is low but its contribution to health is frequently promoted. However, in the US diet, potatoes contribute as much dietary fiber, far more potassium, and a host of similar nutrients as pulses. When prepared to enhance its slowly digested starch content, potatoes produce a moderate glycemic response. In encouraging a shift towards plant-based foods and sustainable diets, the potato can partially replace meat in meat dishes to enhance the overall quality of the diet and reduce meat intake to recommended levels.

Description:

Approximately 11% of individuals with untreated prediabetes progress to diabetes every year. Reversion to normal blood glucose concentrations reduces the incidence of diabetes by 56%. Healthy eating patterns such as the DASH and the Mediterranean Diet have shown that high intakes of fruits, vegetables, whole grains, legumes or pulses, and potatoes are associated with cardiometabolic health. In contrast, dietary patterns rich in meat and sugar-rich foods are associated with increased risk of mortality, type 2 diabetes, and coronary heart disease. These findings suggest that it may be prudent to replace certain foods with fruits and vegetables rather than simply embrace plant-based diets. Small changes that bestow health benefits are likely to be sustainable in the long-term. The objective of the present application is to develop a diet intervention to reverse insulin resistance in an overweight or obese population. The central hypothesis is that in the context of an overall healthy eating pattern, potatoes and pulses will not differ in the glycemic and insulinemic responses, lipid profile, and hsCRP concentration they elicit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults from 18 - 60 years of age

• Body mass index between 25 and 40 kg/m2

• No evidence of diabetes (fasting blood sugar <126 mg/dL).

• HOMA-IR > 2

• Willing to consume the study foods and refrain from eating other foods for eight weeks.

Exclusion Criteria:

• Have type 1 or type 2 diabetes currently being treated by medication.

• Are being treated with medications that have a significant effect on insulin resistance, obesity, serum lipids, and metabolic rate, or medications that significantly increase body weight such as certain antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators.

• Current pregnancy or breastfeeding.

• Women of childbearing potential who are not using an effective method of birth control (i.e., barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), are not surgically sterilized (including tubal ligation and hysterectomy), or not at least two years postmenopausal. All women of childbearing potential will have a pregnancy test performed prior to starting the study treatment in each cohort. If a subject becomes pregnant during the study, they will be dropped from the study.

• Have clinically significant abnormal laboratory markers (as determined by the medical investigator).

• Have contraindications to participation in a diet intervention.

• Are unable to provide a baseline blood sample.

• Have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the foods being tested in the study (determined by the investigative team).

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Other:
• Reduced Meat High Potato Diet
The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
• Reduced Meat High Pulses Diet
The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Alliance for Potato Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Response to the Diet	Change in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome.	Baseline and 8 weeks
Secondary	Insulin Response to the Diet	change in area under the curve for blood insulin (uU/mL/min) concentration in response to the diet. Negative values are considered a better outcome.	Baseline and 8 weeks
Secondary	Cholesterol Response to the Diet	change in blood cholesterol (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.	Baseline and 8 weeks
Secondary	Triglyceride Response to the Diet	change in blood triglyceride (mg/dL) concentration in response to the diet. Negative values are considered a better outcome.	Baseline and 8 weeks
Secondary	LDL Particle Size Response to the Diet	change in LDL particle size (nm) in response to the diet. Negative values are considered a better outcome.	Baseline and 8 weeks
Secondary	hsCRP Response to the Diet	change in hsCRP (mg/L) in response to the diet. Positive values are considered a worse outcome.	Baseline and 8 weeks