Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R25TW009343-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Blum Center for Developing Economies | UNKNOWN |
| Fogarty International Center of the National Institute of Health | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.
The study includes a cross sectional and an interventional component. Maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner.
The short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and LNS. Infants will be test-weighed during the LNS intervention in order to calculate the infant micronutrient intake from the control and LNS intervention days.
Mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. All mothers will receive all treatments.
The mothers will be invited to the clinic on 4 separate occasions. During the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. During the 2-4 visits, the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted milk collection will occur. Subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their meals throughout the day. Infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses |
|
| Group 2 | Experimental | Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose |
|
| Group 3 | Experimental | Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses |
|
| Group 4 | Experimental | Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment 1: Control | Other | No supplement provided. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cobalamin (vitamin B12) in Breast Milk | We are observing the change in breast milk vitamin B12 over the course of 8 hours. | Breast milk cobalamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart. |
| Change in Pyridoxal (vitamin B6) in Breast Milk | We are observing the change in breast milk vitamin B6 over the course of 8 hours. | Breast milk pyridoxal will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart. |
| Change in Riboflavin (vitamin B2) in Breast Milk | We are observing the change in breast milk vitamin B2 over the course of 8 hours. | Breast milk riboflavin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart. |
| Change in Niacin (vitamin B3) in Breast Milk | We are observing the change in breast milk vitamin B5 over the course of 8 hours. | Breast milk niacin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart. |
| Change in Thiamin (vitamin B1) in Breast Milk | We are observing the change in breast milk vitamin B1 over the course of 8 hours. | Breast milk thiamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits/weeks 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal cobalamin (vitamin B12) status | Maternal cobalamin (vitamin B12) status will be measured in blood. | Measured once prior to first study visit (week 1) |
| Maternal pyridoxal (vitamin B6) status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juliana A Haber, B.S. | USDA WHNRC, UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA, ARS, Western Human Nutrition Research Center | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32649760 | Derived | Donohue JA, Solomons NW, Hampel D, Shahab-Ferdows S, Orozco MN, Allen LH. Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial. Am J Clin Nutr. 2020 Sep 1;112(3):669-682. doi: 10.1093/ajcn/nqaa147. |
Not provided
Not provided
Not provided
| Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM) |
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Group 5 | Experimental | Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given |
|
| Group 6 | Experimental | Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose |
|
| Treatment 2: Bolus (LNS) | Dietary Supplement | One LNS supplement provided in a single bolus dose in the morning |
|
| Treatment 3: Divided Dose (LNS) | Dietary Supplement | One LNS supplement provided in 3 separate portions throughout the study visit |
|
Maternal pyridoxal (vitamin B6) will be measured in blood.
| Measured once prior to first study visit (week 1) |
| Maternal riboflavin (vitamin B2) status | Maternal riboflavin (vitamin B2) will be measured in blood. | Measured once prior to first study visit (week 1) |
| Maternal niacin (vitamin B3) status | Maternal niacin (vitamin B5) will be measured in blood. | Measured once prior to first study visit (week 1) |
| Maternal thiamin (vitamin B1) status | Maternal thiamin (vitamin B1) will be measured in blood. | Measured once prior to first study visit (week 1) |
| Change in Infant Milk Consumption | Infants will be test-weighed before and after each feed to calculate milk intake during the study visits. We are observing the change in breast milk intake over the course of 8 hours. | Breast milk consumption for an 8-hour period will be assessed on each of three study visit days (Visits/weeks 2, 3, and 4). Study visits 2, 3, & 4 will each be held approximately 1 week apart. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007041 | Hypoxanthine Phosphoribosyltransferase |
| ID | Term |
|---|---|
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided