Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (NiPPeR)

University of Southampton

Status: Completed

Conditions: Hyperglycemia

Treatments: Dietary Supplement: Study nutritional drink; Dietary Supplement: Standard nutritional drink

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02509988

U1111-1171-8056 (Other Identifier)

13597

2015/00205 (Other Identifier)

34104 (Other Identifier)

Details and patient eligibility

About

The study aims to assess whether a nutritional drink taken before conception and continuing through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and promotes offspring health.

Full description

It is known that maternal insulin resistance and high blood glucose levels in early pregnancy alter the functioning of the placenta in ways that persistently affect the supply of nutrients and fat in the unborn baby. There is an increasing focus on the need to optimise preconception nutrition but as yet, limited preconception interventions that are recognized as promoting health for the mother and her child.

The Investigators will recruit up to 1800 women, aged 18-38 years, who are planning a pregnancy in the United Kingdom, Singapore and New Zealand with the aim of securing 600 or more pregnancies. The participants will be randomly allocated to receive the standard nutritional drink or the study nutritional drink. Women who conceive between one and twelve months after starting the nutritional drink will be followed through pregnancy and studied with their babies for three years after delivery. Various testing will be carried out at relevant time points. Mothers will undergo blood, urine, hair and cheek swab sampling, dual-energy X-ray absorptiometry (DXA) scans along with body measurements and health and lifestyle questionnaires. Infants will undergo hair, cheek swab, urine and stool sampling along with body measurements, measurements of body composition and a DXA scan. Placental, cord and other perinatal tissues/samples will be collected.

The data collected will allow identification of the contributions of nutritional and lifestyle factors, social and economic status, ethnicity, genetics and metabolomics and gut microbes to maintaining healthy glucose metabolism in pregnancy, enhancing fertility, mood and reproductive outcomes in the mother, and promoting healthy growth, body composition and wellbeing in the children.

The effect of the intervention on the primary outcome will be examined in two special interest groups; i) women who are overweight or obese prior to conception & ii) women with documented evidence of dysglycemia prior to conception.

Enrollment: 1,729 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18-38 years
• Planning to conceive within 6 months
• Able to provide written, informed consent
• In Singapore: Chinese, Malay and Indian ethnicity or mixed Chinese/Malay/Indian ethnicity

Exclusion criteria

• Pregnant or lactating at recruitment
• Assisted fertility, apart from those taking clomiphene or letrozole alone
• Pre-existing diabetes (type 1 or type 2)
• Oral or implanted contraception currently or in the last month, or with an Intrauterine Contraceptive Device (IUCD) in situ
• On metformin or systemic steroids currently or in the last month
• Known serious food allergy
• Not able to give informed consent
• Women on anticonvulsants (who are treated with high dose B vitamins in pregnancy) currently or in the last month
• On treatment for Human Immunodeficiency Virus (HIV), Hepatitis B or C currently or in the last month

The partners of the women (over 16 years of age) will also be invited to participate in the study. After having gained written informed consent, fathers will have blood, urine, hair sampling, cheek swabs and body measurements taken and will complete a health and a lifestyle questionnaire at one of the visits during pregnancy.

The mother will consent for their babies to have body measurements, buccal, hair, stool samples and allergy testing from birth to 3.5 years.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,729 participants in 2 patient groups

Intervention (study nutritional drink)

Experimental group

Description:

Study nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening). The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy.

Treatment:

Dietary Supplement: Study nutritional drink

Control (standard nutritional drink)

Active Comparator group

Description:

Standard nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening). The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy.

Treatment:

Dietary Supplement: Standard nutritional drink