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A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women With Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pistachios consumption of 1.5 oz thrice per week
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Chinese women at the age of 20-45 years, with Han ethnicity and singleton pregnancies Women who are at 20-30 weeks' singleton gestation and have the first onset of hyperglycemia which fulfills at least one of the following criteria: fasting glucose ≥5.1 mmol/L, 1 h glucose ≥10 mmol/L or 2 h glucose ≥8.5 mmol/L during the 2 h 75 g OGTT. Pregestational BMI greater than 24 kg/m2. Willing to comply with the research requirements Exclusion Criteria: Gastrointestinal malabsorption and chronic diseases that alter nutrient metabolism Allergy or intolerance to pistachios Pre-existing diabetes, insulin resistance, impaired fasting glucose or impaired glucose tolerance Pregnancy with more than one fetus Current or planned corticosteroid therapy Current or planned beta adrenergic therapy Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Stand care control group (CG)

Intervention group (IG)

Arm Description

According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for the included participants, who all have the pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating nuts intake of less than 2.5 oz per week.

The participants in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week.

Outcomes

Primary Outcome Measures

Change from baseline Blood glucose response at 2 months
Change from baseline of the blood glucose response (time-in-range (TIR) on CGM, Hgb A1c, area under the curve of postprandial blood glucose (CGM)) after the nutritional management over 2 months
The incidences of adverse maternofetal outcomes
The incidences of adverse maternofetal outcomes: emergency caesarean section (C-section), perineal trauma, pregnancy-induced hypertension and preeclampsia, prematurity, large-for-gestational age, and small-for-gestational age.

Secondary Outcome Measures

Change from baseline the lipid profile at 2 months
Change from baseline of the lipid profile (TG, TC, HDL-C, LDL-C) after the nutritional management over 2 months
Change from baseline the inflammatory factors at 2 months
Change from baseline of the inflammatory factors (IL-6, hsCRP) after the nutritional management over 2 months

Full Information

First Posted
December 29, 2022
Last Updated
June 7, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05694520
Brief Title
A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women With Gestational Diabetes Mellitus
Official Title
A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Gestational diabetes mellitus (GDM) is the hyperglycemia with first onset or recognition during pregnancy, of which prevalence has been sharply increased worldwide in the past decades. Nuts offer numerous health benefits, mainly in relation to cardiovascular diseases as well as other chronic conditions. Pistachios have a balanced nutrition profile with lower fat [polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids (MUFAs)], higher protein, fiber (both soluble and insoluble), potassium, phytosterols, γ-tocopherol, vitamin K, xanthophyll carotenoids and rich antioxidant phytochemical constituents (stigmasterol, campesterol, resveratrol, catechins, lutein and zeaxanthin). Recent researches have found that nutritional intervention of the Mediterranean diet with an enhanced consumption of extra virgin olive oil and pistachios lowered incidence of GDM and other adverse outcomes (urinary tract infections, emergency C-sections, perineal trauma, large-for-gestational-age and small-for gestational age newborns) for pregnant women. Another clinical trial compared the acute metabolic effect of pistachios and isocaloric whole-wheat bread in women with GDM, finding significantly improved glucose and insulin responses, higher GLP-1 and lower gastric inhibitory polypeptide (GIP) levels in those consuming pistachios. However, more compelling evidences are still in need to throw light on the long-term effects of pistachio consumption on maternal and offspring's outcomes for GDM patients. Besides, effects of pistachios on the thorough metabolic profile of GDM patients also need to be elucidated. This study aims to further demonstrate the long-term health effects of pistachio consumption on glycemic control, lipid profile, gut hormone responses, inflammatory condition and pregnancy outcomes for women with GDM. The clinical study is a randomized, controlled, two-arm, parallel trial from the diagnosis of gestational diabetes to delivery consisting of six study visits including screening/consent. A total of 80 singleton pregnant women with confirmed diagnosis of GDM will be consecutively recruited, all with the pregestational body mass index (BMI) greater than 24 kg/m2. All subjects will be randomly assigned to intervention group (IG) or stand care control group (CG)), in an allocation ratio of (1:1) in blocks. According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for the included women with pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating the total nuts intake of less than 2.5 oz per week). While the women in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week. All participants will be followed up in 2 weeks initially and then once every 4-6 weeks until delivery or termination of pregnancy. The effect of different interventions on the glycemic profile (the continuous glucose monitoring (CGM) plus self-monitoring), lipid profile, gut hormone responses, inflammatory factors and metabolomics profiling (multi-omics data) will be monitored and compared. The pregnant outcome of the two groups will be also followed up and compared eventually. With all data reviewed and analyzed, this study will add evidence to the long-term health effect of pistachios on GDM women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All subjects will be randomly assigned to intervention group (IG) or stand care control group (CG)), in an allocation ratio of (1:1) in blocks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stand care control group (CG)
Arm Type
No Intervention
Arm Description
According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for the included participants, who all have the pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating nuts intake of less than 2.5 oz per week.
Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Description
The participants in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week.
Intervention Type
Other
Intervention Name(s)
pistachios consumption of 1.5 oz thrice per week
Intervention Description
According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for all the included participants with pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating the total nuts intake of less than 2.5 oz per week). While the women in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week.
Primary Outcome Measure Information:
Title
Change from baseline Blood glucose response at 2 months
Description
Change from baseline of the blood glucose response (time-in-range (TIR) on CGM, Hgb A1c, area under the curve of postprandial blood glucose (CGM)) after the nutritional management over 2 months
Time Frame
up to 2 months
Title
The incidences of adverse maternofetal outcomes
Description
The incidences of adverse maternofetal outcomes: emergency caesarean section (C-section), perineal trauma, pregnancy-induced hypertension and preeclampsia, prematurity, large-for-gestational age, and small-for-gestational age.
Time Frame
From date of intervention until the date of the delivery or termination of pregnancy, up to 4 months..
Secondary Outcome Measure Information:
Title
Change from baseline the lipid profile at 2 months
Description
Change from baseline of the lipid profile (TG, TC, HDL-C, LDL-C) after the nutritional management over 2 months
Time Frame
up to 2 months
Title
Change from baseline the inflammatory factors at 2 months
Description
Change from baseline of the inflammatory factors (IL-6, hsCRP) after the nutritional management over 2 months
Time Frame
up to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese women at the age of 20-45 years, with Han ethnicity and singleton pregnancies Women who are at 20-30 weeks' singleton gestation and have the first onset of hyperglycemia which fulfills at least one of the following criteria: fasting glucose ≥5.1 mmol/L, 1 h glucose ≥10 mmol/L or 2 h glucose ≥8.5 mmol/L during the 2 h 75 g OGTT. Pregestational BMI greater than 24 kg/m2. Willing to comply with the research requirements Exclusion Criteria: Gastrointestinal malabsorption and chronic diseases that alter nutrient metabolism Allergy or intolerance to pistachios Pre-existing diabetes, insulin resistance, impaired fasting glucose or impaired glucose tolerance Pregnancy with more than one fetus Current or planned corticosteroid therapy Current or planned beta adrenergic therapy Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongrong Li
Phone
8601069154095
Email
lirongrong0331@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongrong Li
Phone
8601069154095
Email
lirongrong0331@163.com

12. IPD Sharing Statement

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A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women With Gestational Diabetes Mellitus

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